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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00274612 |
Purpose
The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of an 8 and 14-week treatment period, respectively.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan Drug: Ramipril |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5-10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring |
| Estimated Enrollment: | 780 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | November 2003 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation approximately less than or equal to 1 year prior to signing informed consent) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations
Show 62 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Ltd./Bracknell |
More Information
| Study ID Numbers: | 502.391 |
| Study First Received: | January 10, 2006 |
| Last Updated: | September 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00274612 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Bundesministerium f. Gesundheit und Frauen Sektion III - Gesundheitswesen; Germany: Bundesinstitute für Arzneimittel und Medizinprodukte; Spain: Ministry of Health; France: Afssaps - French Health Products Safety Agency; Netherlands: Medical Ethics Review Committee (METC); Switzerland: Swissmedic; South Africa: Medicines Control Council |
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Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Ramipril Pharmacologic Actions |
Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |