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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria included, but were not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brescia | 25123 | Italy | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
| 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 |
| Monza (Milan) |
| 20052 |
| Italy |
| Pfizer Investigational Site | Padova | 35128 | Italy |
| Pfizer Investigational Site | Palamós | Gerona | 17230 | Spain |
| Pfizer Investigational Site | Madrid | 28041 | Spain |
| Pfizer Investigational Site | London | EC1M 6BQ | United Kingdom |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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