Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension

Verified by: Abbott, July 2008
First Received: September 13, 2005 | Last Updated: July 9, 2008 | Phase: Phase 4 | Start Date: June 2004
Overall Status: Completed | Estimated Enrollment: 120
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This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement...

Brief Summary

Official Title: “A Multicenter, Open, Phase IV, 24-Hour Ambulatory Blood Pressure Monitoring Study of the Efficacy and Safety of Tarka in Patients With Arterial Hypertension”

This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

  • Drug: trandolapril/verapamil
    • 180/2 mg QD

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in blood pressure from baseline/blood pressure control
    • Time Frame: Baseline to 3 months of Tx
      Safety Issue?: Yes

Secondary Measures

  • Absolute BP reduction from baseline, safety
    • Time Frame: Baseline to 3 months of Tx
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Hypertension

Exclusion Criteria:

  • SBP > 180 mm Hg, DBP > 114 mm Hg
  • Subject has a hypersensitivity to trandolapril or verapamil

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Victor Gorin, MD Study Director Abbott  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00235001

Study ID Number: RUSS-04-01

ClinicalTrials.gov Identifier: NCT00235001

Health Authority: Russia: Pharmacological Committee, Ministry of Health

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00235001