Efficacy and Safety of GMRx2 Compared to Dual Combination... | NCT04518293

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GMRx2	Experimental	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg	Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Drug: telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
Dual - TA	Active Comparator	Telmisartan 20 mg/amlodipine 2.5 mg . At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg	Drug: Telmisartan 20 mg/amlodipine 2.5 mg Drug: telmisartan 40 mg/amlodipine 5 mg
Dual - TI	Active Comparator	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg	Drug: Telmisartan 20 mg/indapamide 1.25 mg Drug: telmisartan 40 mg/indapamide 2.5 mg
Dual - AI	Active Comparator	Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg	Drug: Amlodipine 2.5 mg/indapamide 1.25 mg Drug: amlodipine 5 mg/indapamide 2.5 mg

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg	Drug	Single pill	GMRx2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12	The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12	Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.	Week 12
Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12	The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.	Week 12
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At screening visit

Provided signed consent to participate in the trial.
Adult of age ≥18 years.
Attended automated clinic seated mean systolic blood pressure (SBP) (average of last 2 measurements calculated by the device):

140-179 mmHg on 0 BP-lowering drugs, or 130-170 mmHg on 1 BP-lowering drug, or 120-160 mmHg on 2 BP-lowering drugs, or 110-150 mmHg on 3 BP-lowering drugs.

At randomization visit

Home seated mean SBP 110-154 mmHg in the week prior to the randomization visit.
Adherence of 80-120% to run-in medication.
Tolerated run-in medication.
Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate measures, ≥3 sets of duplicate measures) including at least 1 morning and 1 evening each with ≥2 measures. Morning is defined as any measure in the am and evening as any measure in the pm. Morning and evening do not have to be same day.

Exclusion Criteria:

At screening visit

Receiving 4 or more BP-lowering drugs.
Receiving any BP lowering drugs for indications other than hypertension e.g. heart failure
Pregnant or had a positive pregnancy test or unwilling to undertake a pregnancy test during the trial and up to 30 days after the discontinuation of the trial medication or breastfeeding or of childbearing age and not using an acceptable method of contraception. Acceptable methods of birth control include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization. Contraception should be used for at least 1 month before the screening visit and until the end of trial participation.
Not suitable for participation in a clinical trial according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
Contraindication, including hypersensitivity (e.g. anaphylaxis or angioedema), to the active run-in treatment or to any of the trial medication options in the four randomized groups.
Current/history of transient ischemic attack, stroke, or hypertensive encephalopathy.
Current/history of acute coronary syndrome, unstable angina, myocardial infarction, percutaneous transluminal coronary revascularization, or coronary artery bypass graft.
Current atrial fibrillation. Patients with a history of paroxysmal atrial fibrillation are potentially eligible as long as there has been no episode in the last 3 months, while patient with a history of persistent or permanent atrial fibrillation are not eligible.
Current/history of New York Heart Association class III and IV congestive heart failure.
Current/history of a known secondary cause of hypertension, such as primary aldosteronism, renal artery stenosis, pheochromocytoma, or Cushing's syndrome.
Current/history of substantially uncontrolled diabetes (HbA1c > 11.0%) within last three months.
Current/history of end-stage renal disease or anuria or estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2.
Electrolyte levels that would be regarded as contraindications for any of the potential treatment arms e.g. serum sodium <132mmol/l or >148mmol/l serum potassium <3.1 mmol/l or >5.6 mmol/l.
Current/history of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal range within 6 months.
Current concomitant illness or physical impairment or mental condition that in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.
Arm circumference that is too large (>55 cm) or too small (<15-24 cm) to allow accurate measurement of BP.
Currently taking or might need during the trial, a concomitant treatment which is known to interact with one or more of the trial medications: digoxin, lithium, diabetics receiving aliskiren, moderate and strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, diltiazem], simvastatin >20 mg/day, immunosuppressants.
Might need treatment with drugs that are prohibited during the trial: other antihypertensive drugs, endothelin receptor antagonists, neprilysin inhibitors, or other drugs that may affect BP.
Current surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection) or acute flare of inflammatory bowel disease within one year.
Individuals working >2 nightshifts per week.
Participated in any investigative drug or device trial within the previous 30 days.
History of alcohol or drug abuse within 12 months.

At randomization visit

Unable to adhere to the trial procedures during the run-in treatment period.
Any of the following which in the investigator's judgment may compromise the safety of the participant if randomized to the trial medications:
1. High or low clinic BP levels even in the light of the values for home BP that are available for that participant. The exact levels of BP are not specified, since there is clinical uncertainty as to the relevance of BP levels which are high or low in clinic only; for example, the clinical relevance of 'whitecoat hypertension' is uncertain.
2. High or low home diastolic BP (DBP) levels. The exact levels of DBP is not specified, reflecting clinical uncertainty of the implications of isolated diastolic hypertension. However, home DBP values of >99 mmHg may typically be considered as requiring treatment intensification, and such participants would not be suitable for randomization.
3. Any abnormal laboratory value which in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.
4. Fulfilling any of the exclusion criteria mentioned for the screening visit, when verified again at randomization visit.

Name	Affiliation	Role
Anthony Rodgers, Professor	The George Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Elite Clinical Studies		Phoenix	Arizona	85018	United States
Headlands Research

PubMed Identifier	Type	Citation	Retractions
39426836	Derived	Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee DE, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Lakshman P, Uluwattage W, Hay P, Pereira T, Amarasena N, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Gnanenthiran SR, Whelton PK; GMRx2 Investigators. Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial. Lancet. 2024 Oct 19;404(10462):1536-1546. doi: 10.1016/S0140-6736(24)01744-6.

ID	Title	Description
FG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 10, 2023	Mar 2, 2025

Arm/Group Information

ID	Title	Description
BG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
BG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
BG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet
BG003	Dual - AI	Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet amlodipine 5 mg/indapamide 2.5 mg: oral tablet
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002276 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
New Zealand	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Body Mass Index (BMI)

Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.

Mean

Standard Deviation

Kg/m^2

Title	Denominators	Categories
	ParticipantsBG000545 ParticipantsBG001281 ParticipantsBG002

Weight

Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000545 ParticipantsBG001281 ParticipantsBG002

Height

Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG000545 ParticipantsBG001281 ParticipantsBG002

Smoking

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Alcohol

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Pre-Screening 12-Lead ECG

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Hypertension Status at Screening

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Number of Prior BP Treatments at Screening

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000551 ParticipantsBG001282 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12

The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet
OG003	Dual - AI	Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet amlodipine 5 mg/indapamide 2.5 mg: oral tablet

Units	Counts
Participants	OG000551 OG001282 OG002276 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-4.0± 0.45 OG0011.4± 0.60 OG002-1.5± 0.51 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.	MIANALYZE procedure		<.0001		LS Means Difference	-5.44	Standard Error of the Mean	0.680	2-Sided	95	-6.774	-4.107					Other	The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).

Secondary

Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12

Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6

Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12

Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6

Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12

The percentage of participants achieving averaged clinic SBP <140 mmHg and DBP <90 mmHg at Week 12 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6

The percentage of participants achieving averaged clinic SBP <140 mmHg and DBP <80 mmHg at Week 6 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12

The percentage of participants achieving averaged clinic SBP <130 mmHg and DBP <80 mmHg at Week 12 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6

The percentage of participants achieving averaged clinic SBP <130 mmHg and DBP <80 mmHg at Week 6 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6

Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12

Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6

Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12

Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. Trough values were measured before morning dose of the study medication.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6

Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. Trough values were measured before morning dose of the study medication.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12

The percentage of participants achieving averaged home SBP <135 mmHg and DBP <85 mmHg at week 12 was calculated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6

The percentage of participants achieving averaged home SBP <135 mmHg and DBP <85 mmHg at Week 6 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12

The percentage of participants achieving averaged home SBP <130 mmHg and DBP <80 mmHg at Week 12 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6

The percentage of participants achieving averaged home SBP <130 mmHg and DBP <80 mmHg at Week 6 was evaluated.

Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12

The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.

Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI

Other Pre-specified

Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6

The secondary safety outcome is the proportion of participants who discontinued trial medication due to AE/SAE from randomization to follow-up at Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI

Other Pre-specified

Percentage of Participants With a Serious Adverse Event (SAE) From Randomization to Week 12

The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 12.

Posted

Count of Participants

Participants

At Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serious Adverse Event (SAE) From Randomization to Week 6

The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Symptomatic Hypotension From Randomization to Week 12

The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Symptomatic Hypotension From Randomization to Week 6

The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 12

The secondary safety outcome is the proportion of participants with serum sodium <135 mmol/L at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 6

The secondary safety outcome is the proportion of participants with serum sodium <135 mmol/L at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 12

The secondary safety outcome is the proportion of participants with serum sodium >145 mmol/L at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 6

The secondary safety outcome is the proportion of participants with serum sodium >145 mmol/L at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 12

The secondary safety outcome is the proportion of participants with serum potassium concentration <3.5 mmol/L at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 6

The secondary safety outcome is the proportion of participants with serum potassium concentration below 3.5 mmol/l at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 12

The secondary safety outcome is proportion of participants with serum potassium concentration >5.5 mmol/l at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 6

The secondary safety outcome is proportion of participants with serum potassium concentration >5.5 mmol/L at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 12

The secondary safety outcome was the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 6

The secondary safety outcome is the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Serum Sodium <135mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5mmol/L at Follow-up Week 12

The secondary safety outcome is the proportion of participants with serum sodium <135mmol/L or >145 mmol/L, and/or serum potassium <3.5 mmol/L or >5.5mmol/L at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI

Other Pre-specified

Percentage of Participants With Serum Sodium <135 mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5 mmol/L at Week 6

The secondary safety outcome is proportion of participants with serum sodium <135 mmol/L or >145 mmol/L, and/or serum potassium <3.5 mmol/L or >5.5 mmol/L at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI

Other Pre-specified

Percentage of Participants With Orthostatic Hypotension at Week 6

The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Orthostatic Hypotension at Week 12

The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Orthostatic Hypertension at Week 6

The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 6.

Posted

Count of Participants

Participants

Week 6

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Other Pre-specified

Percentage of Participants With Orthostatic Hypertension at Week 12

The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 12.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill
OG001	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet
OG002	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Not Randomized	Participants who were run-in failure and were not randomized (most common reason being home seated mean SBP of 120-154 mmHg in week prior to randomization visit and other reason).	859	15	859	136	859
EG001	GMRx2	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill	551	22	551	306	551
EG002	Dual - TA	Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet	282	11	282	139	282
EG003	Dual - TI	Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet	276	14	276	142	276
EG004	Dual - AI	Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet amlodipine 5 mg/indapamide 2.5 mg: oral tablet	276	8	276	136	276

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 affected859 at risk EG00114 affected551 at risk EG0026 affected282 at risk EG00312 affected276 at risk EG0047 affected276 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Blood uric acid increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Lacrimal gland abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood glucose increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00142 affected551 at risk EG00215 affected282 at risk EG00319 affected276 at risk EG00426 affected276 at risk
Blood uric acid increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00137 affected551 at risk EG0029 affected282 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG00010 affected859 at risk EG00120 affected551 at risk EG0029 affected282 at risk EG003
Blood sodium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00124 affected551 at risk EG00210 affected282 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00019 affected859 at risk EG00128 affected551 at risk EG00212 affected282 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG00010 affected859 at risk EG00128 affected551 at risk EG0026 affected282 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0006 affected859 at risk EG00115 affected551 at risk EG00213 affected282 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00014 affected859 at risk EG00130 affected551 at risk EG00210 affected282 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00122 affected551 at risk EG00217 affected282 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00128 affected551 at risk EG0028 affected282 at risk EG003
Blood potassium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00114 affected551 at risk EG0022 affected282 at risk EG003
Blood sodium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected859 at risk EG00113 affected551 at risk EG00210 affected282 at risk EG003
Blood potassium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG00116 affected551 at risk EG00212 affected282 at risk EG003
Lipids increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0018 affected551 at risk EG0023 affected282 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected859 at risk EG0019 affected551 at risk EG0026 affected282 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00022 affected859 at risk EG00128 affected551 at risk EG00210 affected282 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0008 affected859 at risk EG00112 affected551 at risk EG0026 affected282 at risk EG003
Hyperuricaemia	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG00111 affected551 at risk EG0023 affected282 at risk EG003
Hyperkalaemia	Investigations	MedDRA 24.0	Systematic Assessment	EG0005 affected859 at risk EG0018 affected551 at risk EG0021 affected282 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0007 affected859 at risk EG00112 affected551 at risk EG0027 affected282 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0016 affected551 at risk EG0024 affected282 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0009 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected859 at risk EG0010 affected551 at risk EG0023 affected282 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0012 affected551 at risk EG0021 affected282 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0012 affected551 at risk EG0020 affected282 at risk EG003
Glomerular filtration rate increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Blood creatine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected859 at risk EG0011 affected551 at risk EG0020 affected282 at risk EG003
Liver function test abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected859 at risk EG0010 affected551 at risk EG0021 affected282 at risk EG003
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected859 at risk EG0010 affected551 at risk EG0020 affected282 at risk EG003

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D013449	Sulfonamides
D000577	Amides
D013450	Sulfones
D013457	Sulfur Compounds
D007211	Indoles