Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 24, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period [ Time Frame: 8 week ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Change History

Complete list of historical versions of study NCT00168779 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in seated peak (1 and 3 hours post dose) cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period [ Time Frame: 8 week ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in seated peak (1 and 3 hours post dose) cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Descriptive Information

Brief Title ^ICMJE

Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension

Official Title ^ICMJE

A Randomized, Double-blind, Placebo-controlled, Forced-titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients Iwth Stage 1 or Stage 2 Hypertension

Brief Summary

The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg / hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg
Drug: valsartan 160 mg / hydrochlorothiazide 25 mg
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1125

Completion Date

July 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Ability to provide written informed consent.
Age 18 years or older
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)

Exclusion Criteria:

Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:
1. are not surgically sterile and/or
2. are nursing or pregnant
3. are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
Known or suspected secondary hypertension.
Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
2. Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
Clinically relevant hypokalemia or hyperkalemia.
Uncorrected volume depletion.
Uncorrected sodium depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
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 six months prior to start of run-in period.
Chronic administration of any medications known to affect blood pressure, exc

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00168779

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

502.476

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP