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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Ramipril; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00281593

1236.1

Details and patient eligibility

About

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.

Enrollment: 1,354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.