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)”

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.

Study Type: Interventional

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

Study Primary Completion Date: June 2005

Intervention(s) in this Clinical Trial

• 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).

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
• Other: 2
• Other: 3

Primary Measures

• Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure
  • Time Frame: 14 weeks
    Safety Issue?: No

Secondary Measures

• Changes in blood pressure, safety.
  • Time Frame: 14 and 26 weeks
    Safety Issue?: Yes
• BP mmHg incremental and absolute change
  • Time Frame: 14 and 26 weeks
    Safety Issue?: Yes
• Adverse events
  • Time Frame: Throughout 26 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Stage 1 or 2 Hypertension

Exclusion Criteria:

• Uncontrolled diabetes
• Subject has a hypersensitivity to ACE inhibitor

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information 1-800-633-9110 Study Director Abbott  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00233532

Study ID Number: CANA-03-003

ClinicalTrials.gov Identifier: NCT00233532

Health Authority: Canada: Ethics Review Committee