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
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

Enrollment:	1461
Study Start Date:	April 2006
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

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 arterybypass 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 136 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1235.1
Study First Received:	January 24, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00281580
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
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 January 15, 2009