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

This study has been completed.

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00281580
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Telmisartan
Drug: Amlodipine
Phase III

MedlinePlus related topics:   High Blood Pressure   

Drug Information available for:   Telmisartan    Amlodipine    Amlodipine besylate   

U.S. FDA Resources

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Secondary Outcome 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

Estimated Enrollment:   1461
Estimated Study Completion Date:   December 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281580

Show 110 study locations  Show 110 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim Study Coordinator     Boehringer Ingelheim Pharmaceuticals    
  More Information


Study ID Numbers:   1235.1
First Received:   January 24, 2006
Last Updated:   March 6, 2008
ClinicalTrials.gov Identifier:   NCT00281580
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Vascular Diseases
Telmisartan
Angiotensin II
Amlodipine
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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