Status:
COMPLETED
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Main 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
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1461 Patients enrolled
Trial Details
Trial ID
NCT00281580
Start Date
April 1 2006
Last Update
March 27 2014
Active Locations (136)
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1
1235.1.457 Boehringer Ingelheim Investigational Site
Fairhope, Alabama, United States
2
1235.1.368 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
3
1235.1.389 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
4
1235.1.411 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States