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

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

The Effects of Doxazosin Gastrointestinal Therapeutic System (GITS) on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensives on Drug Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Italy
      • Brescia, Italy, 25123
        • Pfizer Investigational Site
      • Monza (Milan), Italy, 20052
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
    • Gerona
      • Palamos, Gerona, Spain, 17230
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, EC1M 6BQ
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 11 weeks
11 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)
Time Frame: 9 weeks
9 weeks
HgbA1C
Time Frame: 9 weeks
9 weeks
24-hour systolic ABP and 24-hour ambulatory heart rate
Time Frame: 9 weeks
9 weeks
daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate
Time Frame: 9 weeks
9 weeks
Sitting and standing clinic blood pressure (BP) and heart rate
Time Frame: 9 weeks
9 weeks
24-hour ABP smoothness index
Time Frame: 9 weeks
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
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0351051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Doxazosin gastrointestinal therapeutic system (GITS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe