A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: irbesartan; placebo; PS433540; PS433540; PS433540
Intervention description: 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; 400 mg (4 x 100 mg capsules) once daily for 12 weeks; 800 mg (8 x 100 mg capsules) once daily for 12 weeks
Intervention MeSH terms: Irbesartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypertension; High Blood Pressure

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 18 - 70 years

          -  Mean seated Systolic Blood Pressure (SBP) ≥ 140 mmHg and < 180 mmHg and mean seated
             Diastolic Blood Pressure (DBP) > 90 and < 109 mmHg at two consecutive qualifying
             visits (Visits 3/3.5 and Visit 4). The mean difference in DBP between the two
             consecutive qualifying visits must be ≤ 10 mmHg.

          -  Women of child-bearing potential (WOCBP) must use two reliable forms of contraception
             if sexually active. Alternatively, female subjects must be postmenopausal (for at
             least 1 year).

        Exclusion Criteria:

          -  Subjects with serious disorders which may limit the ability to evaluate the efficacy
             or safety of PS433540, including cardiovascular (includes subjects who are known to
             have coronary artery disease), renal (including the absence of one kidney), pulmonary,
             hepatic, gastrointestinal (including clinically significant malabsorption),
             endocrine/metabolic, hematologic, neurologic and psychiatric diseases.

          -  History of malignancy other than adequately treated basal cell or squamous cell skin
             cancer.

          -  Subjects with a history of myocardial infarction or New York Heart Association (NYHA)
             class II-IV heart failure.

          -  Subjects with a history of cerebrovascular accident or transient ischemic attack.

          -  Subjects with clinically significant cardiac conduction defects, including second or
             third degree Atrioventricular Block (AV block), left bundle branch block, sick sinus
             syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any
             arrhythmia requiring medication.

          -  Subjects with hemodynamically significant valvular disease.

          -  Subjects with history of type 1 diabetes mellitus and subjects with a history of type
             2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or
             exenatide) are excluded.