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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Victor Gorin, MD Study Director Abbott  

Information obtained from ClinicalTrials.gov on September 05, 2008

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