Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-02-29

Brief Summary

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The primary objective was to determine the effects of the Gastrointestinal Therapeutic System (GITS) formulation of Doxazosin when used in combination therapy with the 5 major classes of antihypertensive agents as measure by 24-hour diastolic blood pressure.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Doxazosin gastrointestinal therapeutic system (GITS)

Intervention Type DRUG

4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).

Interventions

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Doxazosin gastrointestinal therapeutic system (GITS)

4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eligible subjects were males or females ≥18 years of age with a diagnosis of primary essential hypertension and currently taking 1 or 2 individual antihypertensive agents
* Dosing for entry antihypertensive medication was at the accepted efficacious dose or the maximum tolerated dose and had to be stable for at least 4 weeks prior to study entry
* Subjects were required to have clinic sitting DBP ≥95 and ≤110 mmHg and SBP ≥140 and ≤180 mmHg as an average of 3 readings on their current antihypertensive therapy at visits 1 and 2

Exclusion Criteria

* Subjects taking antihypertensive medications for other indications (i.e. arrhythrma, unstable angina, CHF, etc.)
* Orthostatic hypotension, defined as a decrease of at least 20 mmHg systolic or 1OmmHg diastolic pressure between sitting and standing blood pressures after 2 rmnutes, or known fluid depletion.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No