NCT00233532

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_4 hypertension

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
Last Updated

July 22, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

July 18, 2008

Conditions

Hypertension

Keywords

HypertensionTrandolapril

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure

    14 weeks

Secondary Outcomes (3)

  • Changes in blood pressure, safety.

    14 and 26 weeks

  • BP mmHg incremental and absolute change

    14 and 26 weeks

  • Adverse events

    Throughout 26 weeks

Study Arms (3)

1

OTHER
Drug: Trandolapril

2

OTHER
Drug: Trandolapril

3

OTHER
Drug: Trandolapril

Interventions

TrandolaprilDRUG

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).

Also known as: ABT-TARKA, trandolapril/verapamil, TARKA
123

Eligibility Criteria

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

You may qualify if:

  • Stage 1 or 2 Hypertension

You may not qualify if:

  • Uncontrolled diabetes
  • Subject has a hypersensitivity to ACE inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

trandolaprilVerapamil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Global Medical Information 1-800-633-9110

    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 6, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2005

Last Updated

July 22, 2008

Record last verified: 2008-07