Efficacy and Safety of GMRx2 Compared to Placebo for the... | NCT04518306

Label	Type	Description	Intervention Names
Triple ¼ (GMRx2)	Experimental	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg	Drug: Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg
Triple ½ (GMRx2)	Active Comparator	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg	Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg	Drug	Oral tablets	Triple ¼ (GMRx2)

Measure	Description	Time Frame
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4	Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP>60 mmHg and <250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.	Randomization to Week 4

Measure	Description	Time Frame
Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4	Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP>60 mmHg and <250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.	Randomization to Week 4

Measure	Description	Time Frame
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE) or a Serious Adverse Event (SAE) From Randomization to Week 4	The primary safety outcome is percentage of participants discontinued trial medication due to an Adverse Event (AE) or a Serious Adverse Event (SAE) from randomization to Week 4.	Randomization to Week 4

Eligibility Module

Eligibility Criteria

Inclusion Criteria

At screening visit:

Provided signed consent to participate in the trial.
Adult aged ≥18 years.
Low calculated CV risk according to local guidelines such that pharmacological BP-lowering treatment is not mandatory: e.g. Pooled Cohorts Equation 10-years ASCVD risk <10% in the USA.
Likely diagnosis of hypertension, defined as one or more of:
- automated SBP at this clinic visit according to trial methods (see Appendix 2) of ≥130mmHg on no BP lowering medicines or ≥120mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of office SBP ≥ 140 mmHg and/or DBP ≥ 90mmHg on no BP lowering medicines or SBP ≥ 130 mmHg and/or DBP ≥ 85mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of home SBP ≥ 130 mmHg and/or DBP ≥ 80mmHg on no BP lowering medicines or SBP ≥ 120 mmHg and/or DBP ≥ 75mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of ambulatory daytime SBP ≥ 130 mmHg and/or DBP ≥ 80mmHg on no BP lowering medicines or SBP ≥ 120 mmHg and/or DBP ≥ 75mmHg on 1 BP lowering medicine that will be stopped at this visit
No contraindication to trial medications, including 2-weeks placebo run-in and 4-weeks randomized treatment period with GMRx2 (dose version 1 or 2) or placebo.

At randomization visit:

Home seated mean SBP 130-154 mmHg in the week before the randomization visit.
Adherence of 80-120% to placebo run-in.
Tolerated placebo run-in.
Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate 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 2 or more BP-lowering drugs.
Clinic seated mean SBP ≥160 mmHg and/or DBP ≥100 mmHg.
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 any of the 3 trial medications.
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/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.
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 (<20 cm) to allow accurate measurement of BP.
Currently taking or might need during the trial, a concomitant treatment which is known to interact significantly with the trial medication: 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 (see Error! Reference source not found.).
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-night shifts per week.
Participated in any investigational 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 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/low in clinic only; for example the clinical relevance of 'whitecoat hypertension' is uncertain.
2. High or low home DBP levels. The exact levels of DBP are not specified, reflecting clinical uncertainty of for example 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.
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.
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
41180852	Derived	Salam A, de Silva HA, Ojji D, de Silva AP, Galappatthy G, Lakshman P, Kumanan T, Mayurathan G, Pereira T, Rahuman M, Ranasinghe G, Rasnayake L, Uluwattage W, Constantine GR, Kandeepan T, Sani MU, Kumar A, Pant R, Cushman WC, Di Tanna GL, Grobbee D, Narkiewicz K, Oparil S, Poulter NR, Schlaich MP, Schutte AE, Spiering W, Williams B, Wright JT Jr, Gianacas C, Shanthakumar M, Liu X, Freed R, Whelton PK, Rodgers A. Long-Term Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination for the Treatment of Hypertension. Glob Heart. 2025 Oct 31;20(1):102. doi: 10.5334/gh.1481. eCollection 2025.
39217570

ID	Title	Description
FG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 22, 2023	Mar 2, 2025

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 4

Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP>60 mmHg and <250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Units	Counts
Participants	OG000113 OG001119 OG00263

Title

Denominators

Categories

Title	Measurements
	OG000-9.6± 1.00 OG001-10.4± 1.33 OG002-2.2± 1.16

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 OG002	The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4	MIANALYZE procedure		<0.0001	No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo	LS Means Difference	-7.33	Standard Error of the Mean	1.451	2-Sided	95	-10.176	-4.486					Superiority

Secondary

Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo

Secondary

Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4

Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP>40mmHg and <150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4

The percentage of participants achieving averaged clinic SBP <140 and DBP <90 mmHg at Week 4 was evaluated.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Secondary

Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4

The percentage of participants achieving averaged clinic SBP <130 and DBP <80 mmHg at Week 4 was evaluated. Participants were analyzed in the treatment group to which they have been randomized.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo

Secondary

Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002

Secondary

Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4

Difference in change in trough home SBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Secondary

Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4

Difference in change in trough home DBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. To evaluate the difference in change, least squares mean change value is reported.

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Least Squares Mean

Standard Error

mmHg

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4

The percentage of participants achieving home seated mean SBP <135 and DBP <85 mmHg at Week 4 was evaluated

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Secondary

Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4

The percentage of participants achieving averaged home seated mean SBP <130 and DBP <80 mmHg at Week 4 was evaluated

Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized.

Posted

Count of Participants

Participants

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE) or a Serious Adverse Event (SAE) From Randomization to Week 4

The primary safety outcome is percentage of participants discontinued trial medication due to an Adverse Event (AE) or a Serious Adverse Event (SAE) from randomization to Week 4.

Analysis was done on safety population. The Safety Set is defined as all participants who took at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety endpoints, participants were analyzed in the treatment group they actually received. One participant each from Triple ½ (GMRx2) and Placebo group did not receive randomly assigned treatment during "Randomization to Week 4" period.

Posted

Count of Participants

Participants

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4

Other Pre-specified

Percentage of Participants With an Serious Adverse Event (SAE) From Randomization to Week 4

The secondary outcome is percentage of participants with an SAE from randomization to Week 4

Posted

Count of Participants

Participants

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4

Other Pre-specified

Percentage of Participants With Symptomatic Hypotension From Randomization to Week 4

The Secondary Safety Outcome is percentage of participants with symptomatic hypotension from randomization to Week 4

Posted

Count of Participants

Participants

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 4

The Secondary safety outcome is percentage of participants with serum sodium concentration below 135 mmol/l at Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 4

The Secondary safety outcome is percentage of participants with serum sodium concentration above 145 mmol/l at Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

The Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 4

The secondary safety outcome is percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 4

The secondary safety outcome is percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 4.

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants With eGFR Drop of Over 30% From Randomization to Week 4

The secondary safety outcome is percentage of participants with eGFR drop of over 30% from randomization to Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

Randomization to Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

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 Week 4

The secondary safety outcome is 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 Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants With Postural Hypotension at Week 4

The secondary safety outcome percentage of participants with postural hypotension at Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Pre-specified

Percentage of Participants With Postural Hypertension at Week 4

The secondary safety outcome is percentage of participants with postural hypertension at Week 4

The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

Posted

Count of Participants

Participants

At Week 4

ID	Title	Description
OG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
OG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
OG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood uric acid increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected113 at risk EG0015 events5 affected119 at risk EG0021 events1 affected63 at risk EG0030 events0 affected460 at risk
Blood sodium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0021 events1 affected63 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0021 events1 affected63 at risk EG003
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0006 events5 affected113 at risk EG0012 events2 affected119 at risk EG0027 events5 affected63 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0013 events3 affected119 at risk EG0020 events0 affected63 at risk EG003
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0021 events1 affected63 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0021 events1 affected63 at risk EG003
Blood glucose increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood potassium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0021 events1 affected63 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0020 events0 affected63 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0021 events1 affected63 at risk EG003
Blood potassium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected113 at risk EG0010 events0 affected119 at risk EG0021 events1 affected63 at risk EG003
Lipids abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood cholesterol decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood pressure diastolic increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Low density lipoprotein decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood creatinine abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0013 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood potassium abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood potassium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Blood sodium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
High density lipoprotein abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Lipids increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Low density lipoprotein abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Head discomfort	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Lethargy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Presyncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Hypercholesterolaemia	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Chest discomfort	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Feeling hot	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Gastroenteritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Glomerular filtration rate abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG003
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000077333	Telmisartan
D017311	Amlodipine
D007190	Indapamide

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

ID	Title	Description
BG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4
BG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4
BG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Triple ¼ (GMRx2)	Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	113	0	113	25	113
EG001	Triple ½ (GMRx2)	Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	119	3	119	32	119
EG002	Placebo	Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.	63	2	63	10	63
EG003	Not Randomized	Participants who were run-in failure and were not randomized	460	2	460	17	460

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cerebrovascular accident	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0011 events1 affected119 at risk EG0020 events0 affected63 at risk EG0030 events0 affected460 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0012 events2 affected119 at risk EG0022 events2 affected63 at risk EG003
Arteritis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected113 at risk EG0010 events0 affected119 at risk EG0020 events0 affected63 at risk EG003