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A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00522925•Ligand Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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).

Locations (15)

Premiere Pharmaceutical Research, LLC

Tempe, Arizona, United States

Clinical Trials Research

Lincoln, California, United States

Long Beach Center for Clinical Research

Long Beach, California, United States

National Research Institute

Los Angeles, California, United States

Sacramento Research Medical Group

Sacramento, California, United States

Orange County Research Center

Tustin, California, United States

Westlake Medical Center

Westlake Village, California, United States

University Clinical Research Deland, LLC

DeLand, Florida, United States

Alan Graff, MD PA

Fort Lauderdale, Florida, United States

Cedar Crosse Research Center

Chicago, Illinois, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

April 1, 2008

Completion Date

May 1, 2008

Last Updated

September 16, 2011

Enrollment

280

ACTUAL participants

Conditions

Hypertension

Interventions

PS433540

DRUG

placebo

DRUG

PS433540

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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