Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

June 17, 2014 updated by: Boehringer Ingelheim

A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

894

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • 502.550.35901 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35902 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35903 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35904 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35905 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35908 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35909 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35910 Boehringer Ingelheim Investigational Site
      • Sofia, Bulgaria
        • 502.550.35911 Boehringer Ingelheim Investigational Site
      • Stara Zagora, Bulgaria
        • 502.550.35906 Boehringer Ingelheim Investigational Site
  • China
      • Changsha, China
        • 502.550.86004 Boehringer Ingelheim Investigational Site
      • Guangzhou, Guangdong Province, China
        • 502.550.86003 Boehringer Ingelheim Investigational Site
      • QingDao, China
        • 502.550.86008 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 502.550.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 502.550.86002 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 502.550.86009 Boehringer Ingelheim Investigational Site
      • Tianjin, China
        • 502.550.86007 Boehringer Ingelheim Investigational Site
      • Zhengzhou, China
        • 502.550.86010 Boehringer Ingelheim Investigational Site
  • France
      • Aigrefeuille S/Maine, France
        • 502.550.3302D Boehringer Ingelheim Investigational Site
      • Aix-en-Provence, France
        • 502.550.3305I Boehringer Ingelheim Investigational Site
      • Aubagne, France
        • 502.550.3305G Boehringer Ingelheim Investigational Site
      • Briollay, France
        • 502.550.3301H Boehringer Ingelheim Investigational Site
      • Cholet, France
        • 502.550.3301K Boehringer Ingelheim Investigational Site
      • Corsept, France
        • 502.550.3302I Boehringer Ingelheim Investigational Site
      • Donges, France
        • 502.550.3302C Boehringer Ingelheim Investigational Site
      • La Montagne, France
        • 502.550.3302B Boehringer Ingelheim Investigational Site
      • Louvigné de Bais, France
        • 502.550.3306A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3303A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3303D Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3303F Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3304A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3304D Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3304F Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3304J Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 502.550.3305A Boehringer Ingelheim Investigational Site
      • Murs Erigne, France
        • 502.550.3301A Boehringer Ingelheim Investigational Site
      • Murs-Erigne, France
        • 502.550.3301I Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 502.550.3302A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 502.550.3302E Boehringer Ingelheim Investigational Site
      • Parcay-les-Pins, France
        • 502.550.3301E Boehringer Ingelheim Investigational Site
      • Roquevaire, France
        • 502.550.3303C Boehringer Ingelheim Investigational Site
      • Segre, France
        • 502.550.3301F Boehringer Ingelheim Investigational Site
      • St Aubin les Châteaux, France
        • 502.550.3302G Boehringer Ingelheim Investigational Site
      • St Jouan des Guerets, France
        • 502.550.3306F Boehringer Ingelheim Investigational Site
      • Thouars, France
        • 502.550.3307A Boehringer Ingelheim Investigational Site
      • Vihiers, France
        • 502.550.3301J Boehringer Ingelheim Investigational Site
  • Georgia
      • Tbilisi, Georgia
        • 502.550.99501 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99502 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99503 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99504 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99505 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99506 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99507 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 502.550.99508 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Cheonan, Korea, Republic of
        • 502.550.82008 Boehringer Ingelheim Investigational Site
      • Daegu, Korea, Republic of
        • 502.550.82009 Boehringer Ingelheim Investigational Site
      • Goyang, Korea, Republic of
        • 502.550.82001 Boehringer Ingelheim Investigational Site
      • Gwangju, Korea, Republic of
        • 502.550.82003 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82011 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82012 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 502.550.82013 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 502.550.82004 Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • 502.550.82010 Boehringer Ingelheim Investigational Site
  • Romania
      • Baia Mare Maramures, Romania
        • 502.550.40002 Boehringer Ingelheim Investigational Site
      • Braila, Romania
        • 502.550.40003 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 502.550.40001 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 502.550.40010 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 502.550.40012 Boehringer Ingelheim Investigational Site
      • Cluj Napoca, Romania
        • 502.550.40009 Boehringer Ingelheim Investigational Site
      • Cluj Napoca, Romania
        • 502.550.40011 Boehringer Ingelheim Investigational Site
      • Iasi, Romania
        • 502.550.40006 Boehringer Ingelheim Investigational Site
      • Oradea, Romania
        • 502.550.40004 Boehringer Ingelheim Investigational Site
      • Sibiu, Romania
        • 502.550.40005 Boehringer Ingelheim Investigational Site
      • Tg. Mures, Romania
        • 502.550.40008 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 502.550.07001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 502.550.07002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 502.550.07003 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 502.550.07004 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 502.550.07005 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 502.550.07006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 502.550.07007 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 502.550.07008 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 502.550.07009 Boehringer Ingelheim Investigational Site
      • St.Petersburg, Russian Federation
        • 502.550.07010 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Athens, Alabama, United States
        • 502.550.01008 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, United States
        • 502.550.01019 Boehringer Ingelheim Investigational Site
    • California
      • Lomita, California, United States
        • 502.550.01015 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 502.550.01003 Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • 502.550.01014 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • 502.550.01002 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Iberia, Louisiana, United States
        • 502.550.01011 Boehringer Ingelheim Investigational Site
      • New Orleans, Louisiana, United States
        • 502.550.01009 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States
        • 502.550.01018 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 502.550.01006 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 502.550.01016 Boehringer Ingelheim Investigational Site
      • Greensboro, North Carolina, United States
        • 502.550.01007 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 502.550.01005 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 502.550.01001 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 502.550.01017 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 502.550.01020 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 502.550.01012 Boehringer Ingelheim Investigational Site
    • Virginia
      • Arlington, Virginia, United States
        • 502.550.01004 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  1. 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.
  2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  3. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
  4. Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg
  5. 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.
  6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
  7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
  8. Uncorrected sodium or volume depletion
  9. Primary aldosteronism.
  10. Hereditary fructose intolerance
  11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  12. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)
  13. 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)
  14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
  15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  16. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%
  17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  18. History of drug or alcohol dependency within 6 months prior to signing the informed consent form
  19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
  20. Any investigational drug therapy within 1 month of signing the informed consent
  21. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
  22. 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)
  23. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Telmisartan
Telmisartan 80 mg
Drug: Telmisartan
Telmisartan 80mg
EXPERIMENTAL: Telmisartan/hydrochlorothiazide
Telmisartan80mg/Hydrochlorothiazide25mg
Drug: Telmisartan
Telmisartan 80mg
Drug: Hydrochlorothiazide
Hydrochlorothiazide25mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Seated Trough Cuff SBP to Week 5
Time Frame: Baseline and 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
Time Frame: Baseline and Week 3
The SBP value at baseline was subtracted from the SBP value at Week 3.
Baseline and Week 3
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7
Time Frame: Baseline and Week 7
The DBP value at baseline was subtracted from the DBP value at Week 7.
Baseline and Week 7
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7
Time Frame: Week 7 timepoint
SBP control is defined as SBP < 140 mmHg.
Week 7 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5
Time Frame: Week 5 timepoint
SBP control is defined as SBP < 140 mmHg
Week 5 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3
Time Frame: Week 3 timepoint
SBP control is defined as SBP < 140 mmHg
Week 3 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
Time Frame: Week 7 timepoint
DBP control is defined as DBP<90 mmHg
Week 7 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5
Time Frame: Week 5 timepoint
DBP control is defined as DBP<90 mmHg
Week 5 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3
Time Frame: Week 3 timepoint
DBP control is defined as DBP<90 mmHg
Week 3 timepoint
Number of Patients With Blood Pressure (BP) Control at Week 7
Time Frame: Week 7 timepoint
BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP
Week 7 timepoint
Number of Patients With BP Control at Week 7
Time Frame: Week 7 timepoint
BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP
Week 7 timepoint
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7
Time Frame: Week 7 timepoint
SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg
Week 7 timepoint
Number of Participants With DBP Response at Week 7
Time Frame: Week 7 timepoint
DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg
Week 7 timepoint
BP Categories at Week 7
Time Frame: Week 7 timepoint

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)
Week 7 timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.550
  • 2008-007711-32 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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