NCT00235001

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

July 10, 2008

Status Verified

July 1, 2008

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

July 9, 2008

Conditions

Hypertension

Keywords

HypertensionTarka

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure from baseline/blood pressure control

    Baseline to 3 months of Tx

Secondary Outcomes (1)

  • Absolute BP reduction from baseline, safety

    Baseline to 3 months of Tx

Study Arms (1)

1

EXPERIMENTAL
Drug: trandolapril/verapamil

Interventions

trandolapril/verapamilDRUG

180/2 mg QD

Also known as: ABT-TARKA, Tarka
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information-Abbott

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

trandolaprilVerapamil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Victor Gorin, MD

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2006

Last Updated

July 10, 2008

Record last verified: 2008-07

Locations

US(1)