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

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ClinicalTrials.gov Identifier: NCT00281593
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : December 28, 2017
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Ramipril Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1354 participants
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study
Study Start Date : April 2006
Actual Primary Completion Date : April 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281593


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00281593    
Other Study ID Numbers: 1236.1
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Ramipril
Antihypertensive Agents
 Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors