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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00235001
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : July 10, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: trandolapril/verapamil Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: trandolapril/verapamil
180/2 mg QD
Other Names:
  • ABT-TARKA
  • Tarka


Outcome Measures

Primary Outcome Measures :
  1. Change in blood pressure from baseline/blood pressure control [ Time Frame: Baseline to 3 months of Tx ]

Secondary Outcome Measures :
  1. Absolute BP reduction from baseline, safety [ Time Frame: Baseline to 3 months of Tx ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peter Bacher, MD, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00235001     History of Changes
Other Study ID Numbers: RUSS-04-01
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: July 10, 2008
Last Verified: July 2008

Keywords provided by Abbott:
Hypertension
Tarka

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