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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00235001
First received: September 13, 2005
Last updated: July 9, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: trandolapril/verapamil
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in blood pressure from baseline/blood pressure control [ Time Frame: Baseline to 3 months of Tx ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute BP reduction from baseline, safety [ Time Frame: Baseline to 3 months of Tx ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: June 2004
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trandolapril/verapamil
180/2 mg QD
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • Tarka

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension

Exclusion Criteria:

  • SBP > 180 mm Hg, DBP > 114 mm Hg
  • Subject has a hypersensitivity to trandolapril or verapamil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235001

Locations
United States, Illinois
Global Medical Information-Abbott
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Victor Gorin, MD Abbott
  More Information

No publications provided

Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00235001     History of Changes
Other Study ID Numbers: RUSS-04-01
Study First Received: September 13, 2005
Last Updated: July 9, 2008
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Abbott:
Hypertension
Tarka

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Verapamil
Trandolapril
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014