NCT00646841

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_4 hypertension

Geographic Reach
3 countries

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

March 26, 2008

Last Update Submit

January 26, 2021

Conditions

Hypertension

Keywords

Essential hypertension, doxazosin, ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)

    9 weeks

  • HgbA1C

    9 weeks

  • 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

  • Sitting and standing clinic blood pressure (BP) and heart rate

    9 weeks

  • +2 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Drug: Doxazosin gastrointestinal therapeutic system (GITS)

Interventions

Doxazosin gastrointestinal therapeutic system (GITS)DRUG

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

A

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Brescia, 25123, Italy

Location

Pfizer Investigational Site

Monza (Milan), 20052, Italy

Location

Pfizer Investigational Site

Padua, 35128, Italy

Location

Pfizer Investigational Site

Palamós, Gerona, 17230, Spain

Location

Pfizer Investigational Site

Madrid, 28041, Spain

Location

Pfizer Investigational Site

London, EC1M 6BQ, United Kingdom

Location

Pfizer Investigational Site

Location

Related Links

MeSH Terms

Conditions

HypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

February 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

GB(1)ES(2)IT(3)