Skip to main content
OpenTrials
Completed

NCT Number: NCT00522925

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premiere Pharmaceutical Research, LLC, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PS433540

Drug

200mg capsule, once daily for 28 days

Placebo

Drug

placebo capsule, once daily for 28 days

Primary outcomes

  1. Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure

    Time frame: 4 weeks of treatment with PS43540

Secondary outcomes

  1. Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure

    Time frame: 4 weeks of treatment with PS43540

  2. Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure

    Time frame: 4 weeks of treatment with PS43540

Sponsors and collaborators

Lead sponsor

Ligand Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 30, 2007
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.