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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 9, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change in blood pressure from baseline/blood pressure control after 3 months of treatment

Change History

Complete list of historical versions of study NCT00235001 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Absolute BP reduction from baseline, safety

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: trandolapril/verapamil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hypertension

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00235001

Responsible Party

Peter Bacher, MD, PhD, Abbott

Study ID Numbers ^ICMJE

RUSS-04-01

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Victor Gorin, MD

Abbott

Information Provided By

Abbott

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP