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

NCT00926289 | Completed Phase 4 Results

• 2 other identifiers: 502.5502008-007711-32
• Study Type: interventional
• Target: 894
• Locations: 8 countries
• Sites: 106

Brief Summary

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

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

  Baseline and Week 5

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

  Baseline and Week 3

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

  Baseline and Week 7

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

  Week 7 timepoint

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

  Week 5 timepoint

Study Arms (2)

Telmisartan

ACTIVE COMPARATOR

Telmisartan 80 mg

Drug: Telmisartan

Telmisartan/hydrochlorothiazide

EXPERIMENTAL

Telmisartan80mg/Hydrochlorothiazide25mg

Drug: Telmisartan; Drug: Hydrochlorothiazide

Interventions

Telmisartan DRUG

Telmisartan 80mg

Telmisartan

Hydrochlorothiazide DRUG

Hydrochlorothiazide25mg

Telmisartan/hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (106)

502.550.01008 Boehringer Ingelheim Investigational Site

Athens, Alabama, United States

Location

502.550.01019 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

502.550.01015 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Location

502.550.01003 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

502.550.01014 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

502.550.01002 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

502.550.01011 Boehringer Ingelheim Investigational Site

New Iberia, Louisiana, United States

Location

502.550.01009 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

502.550.01018 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Location

502.550.01006 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

502.550.01016 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

502.550.01007 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

502.550.01005 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

502.550.01001 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

502.550.01017 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

502.550.01020 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

502.550.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

502.550.01004 Boehringer Ingelheim Investigational Site

Arlington, Virginia, United States

Location

502.550.35901 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35902 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35905 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35908 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35909 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35910 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35911 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

502.550.35906 Boehringer Ingelheim Investigational Site

Stara Zagora, Bulgaria

Location

502.550.86004 Boehringer Ingelheim Investigational Site

Changsha, China

Location

502.550.86003 Boehringer Ingelheim Investigational Site

Guangzhou, Guangdong Province, China

Location

502.550.86008 Boehringer Ingelheim Investigational Site

Qingdao, China

Location

502.550.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

502.550.86002 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

502.550.86009 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

502.550.86007 Boehringer Ingelheim Investigational Site

Tianjin, China

Location

502.550.86010 Boehringer Ingelheim Investigational Site

Zhengzhou, China

Location

502.550.3302D Boehringer Ingelheim Investigational Site

Aigrefeuille S/Maine, France

Location

502.550.3305I Boehringer Ingelheim Investigational Site

Aix-en-Provence, France

Location

502.550.3305G Boehringer Ingelheim Investigational Site

Aubagne, France

Location

502.550.3301H Boehringer Ingelheim Investigational Site

Briollay, France

Location

502.550.3301K Boehringer Ingelheim Investigational Site

Cholet, France

Location

502.550.3302I Boehringer Ingelheim Investigational Site

Corsept, France

Location

502.550.3302C Boehringer Ingelheim Investigational Site

Donges, France

Location

502.550.3302B Boehringer Ingelheim Investigational Site

La Montagne, France

Location

502.550.3306A Boehringer Ingelheim Investigational Site

Louvigné-de-Bais, France

Location

502.550.3303A Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3303D Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3303F Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3304A Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3304D Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3304F Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3304J Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3305A Boehringer Ingelheim Investigational Site

Marseille, France

Location

502.550.3301A Boehringer Ingelheim Investigational Site

Mûrs-Erigné, France

Location

502.550.3301I Boehringer Ingelheim Investigational Site

Mûrs-Erigné, France

Location

502.550.3302A Boehringer Ingelheim Investigational Site

Nantes, France

Location

502.550.3302E Boehringer Ingelheim Investigational Site

Nantes, France

Location

502.550.3301E Boehringer Ingelheim Investigational Site

Parçay-les-Pins, France

Location

502.550.3303C Boehringer Ingelheim Investigational Site

Roquevaire, France

Location

502.550.3302G Boehringer Ingelheim Investigational Site

Saint Aubin Les Châteaux, France

Location

502.550.3306F Boehringer Ingelheim Investigational Site

Saint-Jouan-des-Guérets, France

Location

502.550.3301F Boehringer Ingelheim Investigational Site

Segré, France

Location

502.550.3307A Boehringer Ingelheim Investigational Site

Thouars, France

Location

502.550.3301J Boehringer Ingelheim Investigational Site

Vihiers, France

Location

502.550.99501 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99502 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99503 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99504 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99505 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99506 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99507 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.99508 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

502.550.40002 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, Romania

Location

502.550.40003 Boehringer Ingelheim Investigational Site

Brăila, Romania

Location

502.550.40001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

502.550.40010 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

502.550.40012 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

502.550.40009 Boehringer Ingelheim Investigational Site

Cluj-Napoca, Romania

Location

502.550.40011 Boehringer Ingelheim Investigational Site

Cluj-Napoca, Romania

Location

502.550.40006 Boehringer Ingelheim Investigational Site

Iași, Romania

Location

502.550.40004 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

502.550.40005 Boehringer Ingelheim Investigational Site

Sibiu, Romania

Location

502.550.40008 Boehringer Ingelheim Investigational Site

Tg. Mures, Romania

Location

502.550.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

502.550.07007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

502.550.07008 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

502.550.07009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

502.550.07010 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

502.550.82008 Boehringer Ingelheim Investigational Site

Cheonan, South Korea

Location

502.550.82009 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

502.550.82001 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

502.550.82003 Boehringer Ingelheim Investigational Site

Gwangju, South Korea

Location

502.550.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82007 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82011 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82012 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82013 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

502.550.82004 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

502.550.82010 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22717420 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: May 24, 2011

Record last verified: 2013-12

Locations

GE (8); US (18); RU (10); FR (28); BU (10); CN (8); RO (11); KR (13)