Hypertension
Conditions
Keywords
Essential hypertension, doxazosin, ambulatory blood pressure monitoring
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.
Interventions
DRUGDoxazosin 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).
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | 11 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Serum lipid levels (total cholesterol [TC], HDL cholesterol, calculated LDL cholesterol, triglycerides, calculated HDL/TC ratio) | 9 weeks |
| 24-hour ABP smoothness index | 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 | 9 weeks |
| Sitting and standing clinic blood pressure (BP) and heart rate | 9 weeks |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed