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

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Doxazosin gastrointestinal therapeutic system (GITS)	Phase IV

MedlinePlus related topics:

High Blood Pressure

ChemIDplus related topics:

Doxazosin Doxazosin mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	89
Study Start Date:	February 2003
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646841

Locations


Hungary, NYIREGYHAZA
	Pfizer Investigational Site
	Unknown, NYIREGYHAZA, Hungary, 4400

Ireland, Co Galway
	Pfizer Investigational Site
	Unknown, Co Galway, Ireland

Italy
	Pfizer Investigational Site
	Monza (Milan), Italy, 20052
	Pfizer Investigational Site
	Padova, Italy, 35128
	Pfizer Investigational Site
	Brescia, Italy, 25123

Poland, Jastrzebie Zdroj
	Pfizer Investigational Site
	Unknown, Jastrzebie Zdroj, Poland, 44-330

Spain
	Pfizer Investigational Site
	Madrid, Spain, 28041

Spain, Gerona
	Pfizer Investigational Site
	Palamos, Gerona, Spain, 17230

Spain, Oviedo
	Pfizer Investigational Site
	Unknown, Oviedo, Spain, 33006

United Kingdom
	Pfizer Investigational Site
	LONDON, United Kingdom, EC1M 6BQ

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0351051
First Received:	March 26, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00646841
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Essential hypertension, doxazosin, ambulatory blood pressure monitoring

Study placed in the following topic categories:

Vascular Diseases

Essential hypertension

Doxazosin

Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Therapeutic Uses

Physiological Effects of Drugs

Adrenergic Antagonists

Cardiovascular Diseases

Adrenergic alpha-Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00646841