Official Title: “A Prospective Randomized Open-Label Blinded-Endpoint (PROBE) Trial Comparing MICARDIS (Telmisartan) (40-80-80 mg QD) and Ramipril (2.5-5-10 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Telmisartan
• Drug: Ramipril

Primary Measures

• 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 Measures

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274599

Study ID Number: 502.392

ClinicalTrials.gov Identifier: NCT00274599

Health Authority: United States: Food and Drug Administration