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”

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

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

• Drug: Telmisartan
• Drug: Ramipril

Primary Measures

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

Secondary 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00281593

Study ID Number: 1236.1

ClinicalTrials.gov Identifier: NCT00281593

Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)