A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

Completed

Phase 2 Results

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo capsules once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Blinded Placebo Treatment
  • irbesartan (AVAPRO┬«*)Drug
    Other Names: Aprovel®
    Intervention Desc: 300 mg (2 x 150 mg capsules) once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: Irbesartan 300mg
    Description: Irbesartan 300 mg once daily
  • PS433540 (DARA)Drug
    Intervention Desc: 800 mg (8 x 100 mg capsules) once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: PS433540 200mg
    Description: PS433540 200mg once daily
    ARM 2: Kind: Experimental
    Label: PS433540 400mg
    Description: PS433540 400mg once daily
    ARM 3: Kind: Experimental
    Label: PS433540 800mg
    Description: PS433540 800mg once daily

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized into one of 5 arms: 1. Active Comparator Drug: irbesartan 300 mg (2 x 150 mg capsules) once daily for 12 weeks 2: Placebo Comparator Drug: placebo placebo capsules once daily for 12 weeks 3: Experimental Drug: PS433540 200 mg (2 x 100 mg capsules) once daily for 12 weeks 4: Experimental Drug: PS433540 400 mg (4 x 100 mg capsules) once daily for 12 weeks 5: Experimental Drug: PS433540 800 mg (8 x 100 mg capsules) once daily for 12 weeks Blood pressure will be followed from baseline for 12 weeks to determine effectiveness of treatment and dose for PS433540.

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in mean seated SBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo.
Secondary Change from baseline in mean seated DBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo; percentage of patients treated with each dose of PS433540 who achieved blood pressure control, defined as <140/90 mmHg, after 12 weeks of treatment.
Primary 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. 12 weeks No
Secondary 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. 12 weeks No
Secondary 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. 12 weeks No

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