Telmisartan (Micardis) and Ramipril (Altace) - 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:	NCT00281593

Purpose

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

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril Telmisartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 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:

Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary Outcome Measures:

Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

Enrollment:	1354
Study Start Date:	April 2006
Primary Completion Date:	April 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 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: NCT00281593

Show 119 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:	1236.1
Study First Received:	January 24, 2006
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00281593
Health Authority:	Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica); United States: Food and Drug Administration

Study placed in the following topic categories:

Vascular Diseases
Telmisartan
Angiotensin II
Ramipril
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009