Clinical trial NCT00646841: Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients
Official title: The Effects of Doxazosin Gastrointestinal Therapeutic System (GITS) on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensives on Drug Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Essential hypertension, doxazosin, ambulatory blood pressure monitoring
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 11 weeks
Secondary outcomes:
measure: Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)
timeFrame: 9 weeks
measure: HgbA1C
timeFrame: 9 weeks
measure: 24-hour systolic ABP and 24-hour ambulatory heart rate
timeFrame: 9 weeks
measure: daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate
timeFrame: 9 weeks
measure: Sitting and standing clinic blood pressure (BP) and heart rate
timeFrame: 9 weeks
measure: 24-hour ABP smoothness index
timeFrame: 9 weeks
measure: 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
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Monza (Milan)
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palamos
country: Spain
facility: Pfizer Investigational Site
state: Gerona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: