A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension

Study Overview
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Brief Summary
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The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.

Official Title
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Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects With Stage I and II Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: PS433540
* Drug: placebo
* Drug: PS433540


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 30 - 80 years Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP < 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg. Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg Subjects must have a usual daytime schedule. Night shift workers are excluded from participation. Women of child-bearing potential (WOCBP) and male subjects 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, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases. Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months. Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year. Subjects with diabetes mellitus (type I and type II).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Matching Placebo | Drug: placebo<br>* placebo capsule, once daily for 28 days<br>|
| Experimental: 2<br> | Drug: PS433540<br>* 200mg capsule, once daily for 28 days<br>|
| Experimental: 3<br> | Drug: PS433540<br>* 500mg capsule, once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure |  | 4 weeks of treatment with PS43540 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure |  | 4 weeks of treatment with PS43540 | 
| Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure |  | 4 weeks of treatment with PS43540 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, high blood pressure