PROBE Parallel 6-wk Treatment Comparing Telmisartan/HCT (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using ABPM

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

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