Overview

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Amlodipine
Telmisartan
Criteria
Inclusion criteria:

Main 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:

Exclusion Criteria:

1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study;
has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke
within the last six 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 for the past three
months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history
of angioedema or hypersensitivity related to either study drug.

2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury
(mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.