The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,381
4 mg of candesartan as capsule
8 mg candesartan as capsule
20 mg nifedipine as tablet
30 mg nifedipine as tablet
60 mg nifedipine as tablet
3 different placebo tablets corresponding nifedipine doses and 1 placebo capsule corresponding to candesartan doses
16 mg of candesartan as capsule
32 mg of candesartan as capsule
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Deerfield Beach, Florida, United States
Unnamed facility
Deerfield Beach, Florida, United States
Unnamed facility
The primary efficacy variable is the change from baseline in mean seated diastolic blood pressure (MSDBP) at Week 8
Time frame: Baseline taken at Visit 1; primary outcome variable assesed at 8 weeks
Change in mean seated systolic blood pressure (MSSBP) at Week 8
Time frame: 8 weeks
Control rate at Week 8
Time frame: 8 weeks
Response rate at Week 8
Time frame: 8 weeks
Peripheral Edema
Time frame: 8 weeks
Time to achieve first BP control
Time frame: 8 weeks
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Fort Lauderdale, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
West Palm Beach, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Valparaiso, Indiana, United States
...and 147 more locations