Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension - Full Text View

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

This study has been completed.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00281580

Purpose

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pressure.

Condition	Intervention	Phase
Hypertension	Drug: Telmisartan Drug: Amlodipine	Phase III

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Telmisartan Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment

Official Title:	A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-Study

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Efficacy: Change from baseline in seated trough cuff diastolic blood pressure after eight weeks of treatment

Secondary Outcome Measures:

Efficacy: change after 8 wks in: seated cuff SBP; % pts with BP response to treatment; standing DBP and SBP; ABPM overall and hourly BP changes. Safety:AEs, Labs, ECG, Orthostatic BP changes, PR

Estimated Enrollment:	1461
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Male and female patients >= 18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg

Main Exclusion Criteria:

Pregnant
Breast-feeding
Unwilling to use birth control during the study
Secondary hypertension, SBP >= 180 mmHg, DBP >= 120 mmHg
Severe renal dysfunction
Hepatic insufficiency
Stroke within the last 6 months
Myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery
Bypass graft within the past three months
Unstable or uncontrolled diabetes
History of angioedema of either of the study drugs, and hypersensitivity to the study drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281580

Show 110 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	1235.1
First Received:	January 24, 2006
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00281580
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vascular Diseases

Telmisartan

Angiotensin II

Amlodipine

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Calcium Channel Blockers

Enzyme Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Protease Inhibitors

Membrane Transport Modulators

Angiotensin II Type 1 Receptor Blockers

Therapeutic Uses

Angiotensin-Converting Enzyme Inhibitors

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008