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

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: NCT00233532
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : July 22, 2008
Sponsor:
Information provided by:

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
Hypertension Drug: Trandolapril Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2004
Primary Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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
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 [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Changes in blood pressure, safety. [ Time Frame: 14 and 26 weeks ]
  2. BP mmHg incremental and absolute change [ Time Frame: 14 and 26 weeks ]
  3. Adverse events [ Time Frame: Throughout 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 1 or 2 Hypertension

Exclusion Criteria:

  • Uncontrolled diabetes
  • Subject has a hypersensitivity to ACE inhibitor
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): NCT00233532


Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information 1-800-633-9110 Abbott
More Information

Responsible Party: Anita Vanjaka, Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00233532     History of Changes
Other Study ID Numbers: CANA-03-003
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008

Keywords provided by Abbott:
Hypertension
Trandolapril

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Trandolapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents