To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-mod...
Date First Received: January 10, 2006
Last Updated: April 3, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, March 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2002
Overall Status: Completed
Estimated Enrollment: 810
Brief Summary
Official Title: “PROBE Parallel Group 6 wk Treatment Comparing Telmisartan + HCT (40/12.5mg, or 80/12.5mg) With Losartan + HCT (50/12.5mg) Using ABPM in Pts With Mild-to Moderate Hypertension”
Condition Keyword(s):
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-mod hypertensives
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Telmisartan & Hydrochlorothiazide
- Drug: Losartan & Hydrochlorothiazide
- Procedure: ABPM
Outcome Measures for this Clinical Trial
Primary Measures
- To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering DBP during the last 6 hrs of the 24-hr dosing interval in mild-mod hypertensives at the end of a 6-w
Secondary Measures
- Compared MICARDIS® HCT with Hyzaar® at the end of 6 wks treatment in the reduction of SBP during the last 6 hrs of the 24-hr dosing interval; also in 24-hr ABPM mean DBP and SBP; reductions in ABPM mean DBP & SBP (morn, day & night); manual cuff reading
Criteria for Participation in this Clinical Trial
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 October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274638
Study ID Number: 502.387
ClinicalTrials.gov Identifier: NCT00274638
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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