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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antihypertensive Agents

ClinicalTrials.gov processed this record on August 21, 2014