Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00281593
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Study Start: 2006-04
• Primary Completion: 2007-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1354

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (119)

1236.1.511 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

1236.1.574 Boehringer Ingelheim Investigational Site; 🇺🇸 Tempe, Arizona, United States

1236.1.501 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1236.1.557 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1236.1.523 Boehringer Ingelheim Investigational Site; 🇺🇸 Buena Park, California, United States

1236.1.514 Boehringer Ingelheim Investigational Site; 🇺🇸 Concord, California, United States

1236.1.560 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

1236.1.573 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1236.1.516 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1236.1.529 Boehringer Ingelheim Investigational Site; 🇺🇸 Roseville, California, United States

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