Clinical trial NCT00522925: A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
high blood pressure
Lead sponsor: Ligand Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 280
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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).

Primary outcomes:
measure: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure
timeFrame: 4 weeks of treatment with PS43540
Secondary outcomes:
measure: Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure
timeFrame: 4 weeks of treatment with PS43540
measure: Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure
timeFrame: 4 weeks of treatment with PS43540
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research, LLC
state: Arizona
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Group
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Center
state: California
city: Deland
country: United States
facility: University Clinical Research Deland, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Alan Graff, MD PA
state: Florida
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Orland Park
country: United States
facility: Orland Primary Care Specialists
state: Illinois
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Carrolton
country: United States
facility: Punzi Medical Center
state: Texas
city: Madison
country: United States
facility: Gemini Scientific
state: Wisconsin
Study officials:
affiliation: Integrium
name: Joel M Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References: