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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
4 mg/day, and was titrated, if necessary, to 8 mg/day at Week 3 (Visit 5) or Week 5 (Visit 6).
Pfizer Investigational Site
Brescia, Italy
Pfizer Investigational Site
Monza (Milan), Italy
Pfizer Investigational Site
Padova, Italy
Pfizer Investigational Site
Palamós, Gerona, Spain
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
Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio)
Time frame: 9 weeks
HgbA1C
Time frame: 9 weeks
24-hour systolic ABP and 24-hour ambulatory heart rate
Time frame: 9 weeks
daytime and nighttime (2200 to 0600 hours) ABP and ambulatory heart rate
Time frame: 9 weeks
Sitting and standing clinic blood pressure (BP) and heart rate
Time frame: 9 weeks
24-hour ABP smoothness index
Time frame: 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
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Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site