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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Trandolapril

• Registration Number: NCT00233532
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-18
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Stage 1 or 2 Hypertension

Exclusion Criteria

• Uncontrolled diabetes
• Subject has a hypersensitivity to ACE inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Trandolapril	-
1	Trandolapril	-
2	Trandolapril	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure	14 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure, safety.	14 and 26 weeks
BP mmHg incremental and absolute change	14 and 26 weeks
Adverse events	Throughout 26 weeks