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PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

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ClinicalTrials.gov Identifier: NCT00274599
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 8, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Ramipril Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring
Study Start Date : October 2002
Actual Primary Completion Date : December 2003

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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 the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg)

Secondary Outcome Measures :
  1. Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytime and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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): NCT00274599


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

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ClinicalTrials.gov Identifier: NCT00274599    
Other Study ID Numbers: 502.392
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013
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