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

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pressure...

Date First Received: January 24, 2006

Last Updated: March 6, 2008

Verified by: Boehringer Ingelheim Pharmaceuticals, March 2008

Clinical Trial Phase: Phase 3 | Start Date: 

Overall Status: Completed

Estimated Enrollment: 1461

Brief Summary

Official Title: “A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-Study”

Condition Keyword(s):

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pressure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment

Intervention(s) in this Clinical Trial

  • Drug: Telmisartan
  • Drug: Amlodipine

Outcome Measures for this Clinical Trial

Primary Measures

  • Efficacy: Change from baseline in seated trough cuff diastolic blood pressure after eight weeks of treatment

Secondary Measures

  • Efficacy: change after 8 wks in: seated cuff SBP; % pts with BP response to treatment; standing DBP and SBP; ABPM overall and hourly BP changes. Safety:AEs, Labs, ECG, Orthostatic BP changes, PR

Criteria for Participation in this Clinical Trial

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:

  • 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 Sponsor Information

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00281580

Study ID Number: 1235.1

ClinicalTrials.gov Identifier: NCT00281580

Health Authority: United States: Food and Drug Administration

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