The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
261
300 mg (2 x 150 mg capsules) once daily for 12 weeks
placebo capsules once daily for 12 weeks
200 mg (2 x 100 mg capsules) once daily for 12 weeks
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
Time frame: 12 weeks
Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
Time frame: 12 weeks
The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.
Time frame: 12 weeks
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400 mg (4 x 100 mg capsules) once daily for 12 weeks
800 mg (8 x 100 mg capsules) once daily for 12 weeks
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Anaheim, California, United States
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Lincoln, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Tustin, California, United States
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