Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension
To demonstrate that Micardis and Altace when used together are more effective at lowering blood pressure...
Brief Summary
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: Primary Purpose: Treatment
- Study Primary Completion Date: April 2007
Intervention(s) in this Clinical Trial
- Drug: Telmisartan
- Drug: Ramipril
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00281593
