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Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00233532
Collaborator
(none)
2,000
Enrollment
3
Arms

Study Details

Study Description

Brief Summary

The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in Treatment-Naïve and Concurrently Treated Hypertensive Patients (TRAIL)
Study Start Date :
Mar 1, 2004
Actual Primary Completion Date :
Jun 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Drug: Trandolapril
0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA

    		•
    Other: 2

    Drug: Trandolapril
    0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
    Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA

    		•
    Other: 3

    Drug: Trandolapril
    0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).
    Other Names:
  • ABT-TARKA
  • trandolapril/verapamil
  • TARKA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure [14 weeks]

    Secondary Outcome Measures

    1. Changes in blood pressure, safety. [14 and 26 weeks]

    2. BP mmHg incremental and absolute change [14 and 26 weeks]

    3. Adverse events [Throughout 26 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Stage 1 or 2 Hypertension
    Exclusion Criteria:

    • Uncontrolled diabetes

    • Subject has a hypersensitivity to ACE inhibitor

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Global Medical Information 1-800-633-9110, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00233532
    Other Study ID Numbers:
    • CANA-03-003
    First Posted:
    Oct 6, 2005
    Last Update Posted:
    Jul 22, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Hypertension
    Trandolapril
    Additional relevant MeSH terms:
    Hypertension
    Verapamil
    Trandolapril

    Study Results

    No Results Posted as of Jul 22, 2008