Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line... | NCT00926289

ID	Type	Description	Link
2008-007711-32	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
Telmisartan	Active Comparator	Telmisartan 80 mg	Drug: Telmisartan
Telmisartan/hydrochlorothiazide	Experimental	Telmisartan80mg/Hydrochlorothiazide25mg	Drug: Telmisartan Drug: Hydrochlorothiazide

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug	Telmisartan 80mg	Telmisartan
Telmisartan

Measure	Description	Time Frame
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7	The SBP value at baseline was subtracted from the SBP value at Week 7.	Baseline and Week 7

Measure	Description	Time Frame
Change From Baseline in Mean Seated Trough Cuff SBP to Week 5	The SBP value at baseline was subtracted from the SBP value at Week 5.	Baseline and Week 5
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
Age 18 years or older;
Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization
Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Exclusion criteria:

Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg
Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
Uncorrected sodium or volume depletion
Primary aldosteronism.
Hereditary fructose intolerance
Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)
Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
History of drug or alcohol dependency within 6 months prior to signing the informed consent form
Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Any investigational drug therapy within 1 month of signing the informed consent
Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
502.550.01008 Boehringer Ingelheim Investigational Site		Athens	Alabama		United States
502.550.01019 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
22717420	Derived	Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
FG001	Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7

The SBP value at baseline was subtracted from the SBP value at Week 7.

The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 7

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000263 OG001541

Title

Denominators

Categories

Title	Measurements
	OG000-28.5± 0.88 OG001-37.0± 0.62

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	T80+HCTZ25 versus T80 monotherapy	ANCOVA	Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction	<0.0001		Mean Difference (Final Values)	-8.5				95	-10.6	-6.4				No	Superiority or Other

Secondary

Change From Baseline in Mean Seated Trough Cuff SBP to Week 5

The SBP value at baseline was subtracted from the SBP value at Week 5.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 5

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Seated Trough Cuff SBP to Week 3

The SBP value at baseline was subtracted from the SBP value at Week 3.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 3

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7

The DBP value at baseline was subtracted from the DBP value at Week 7.

Posted

Least Squares Mean

Standard Error

mmHg

Baseline and Week 7

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7

SBP control is defined as SBP < 140 mmHg.

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5

SBP control is defined as SBP < 140 mmHg

Posted

Number

Participants

Week 5 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3

SBP control is defined as SBP < 140 mmHg

Posted

Number

Participants

Week 3 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7

DBP control is defined as DBP<90 mmHg

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5

DBP control is defined as DBP<90 mmHg

Posted

Number

participants

Week 5 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3

DBP control is defined as DBP<90 mmHg

Posted

Number

Participants

Week 3 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With Blood Pressure (BP) Control at Week 7

BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With BP Control at Week 7

BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7

SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

Number of Participants With DBP Response at Week 7

DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants	OG000

Secondary

BP Categories at Week 7

BP categories comprise:

BP optimal (SBP <120 mmHg and DBP <80 mmHg)
BP normal (SBP <130 mmHg and DBP <85 mmHg but not 'optimal')
BP high normal (SBP <140 mmHg and DBP <90 mmHg but not 'normal')
Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not 'high normal')
Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not 'Grade 1 hypertension')
Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)

Posted

Number

Participants

Week 7 timepoint

ID	Title	Description
OG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
OG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks

Units	Counts
Participants

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks			1	294	0	294
EG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks			0	594	0	594

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
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D049971	Thiazides

ID	Title	Description
BG000	Telmisartan 40/80 mg	Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
BG001	Telmisartan 40/80 mg + HCTZ 12.5/25 mg	fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
BG002	Total	Total of all reporting groups