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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Doxazosin gastrointestinal therapeutic system (GITS)

• Registration Number: NCT00646841
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Exclusion criteria included, but were not limited to:

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Doxazosin gastrointestinal therapeutic system (GITS)	-

Primary Outcome Measures

Name	Time	Method
To determine the effects of Doxazosin Gastrointestinal Therapeutic System (GITS) 4 or 8mg/day on mean 24-hour diastolic ambulatory blood pressure (ABP) when used in combination therapy in subjects with uncontrolled essential hypertension.	11 weeks

Secondary Outcome Measures

Name	Time	Method
24-hour systolic ABP and 24-hour ambulatory heart rate	9 weeks
daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate	9 weeks
24-hour ABP and ambulatory heart rate between 24 hours (Week 9) and 48 hours (Week 9+1 day) after final dose of Doxazosin GITS	9 weeks
Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)	9 weeks
HgbA1C	9 weeks
24-hour ABP smoothness index	9 weeks
Sitting and standing clinic blood pressure (BP) and heart rate	9 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site