Clinical trial NCT00635232: A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
Official title: A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With 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: 2008-03-13
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.
timeFrame: 12 weeks
measure: The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City
state: Alabama
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research AZ
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research CA
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: Superior Regional Research, LLC
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: Univ. Clinical Research Deland, LLC.
state: Florida
city: Ft. Lauderdale
country: United States
facility: Allan Graff
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Sebastian
country: United States
facility: North County Medical
state: Florida
city: Decatur
country: United States
facility: Q Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Cary
country: United States
facility: Cary Medical Research
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research NC
state: North Carolina
city: Lenoir
country: United States
facility: Northstate Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research NC
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Rersearch
state: North Carolina
city: Winston Salem
country: United States
facility: Peidmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center
state: Ohio
city: Delaware
country: United States
facility: Delaware Smith Clinic
state: Ohio
city: Marion
country: United States
facility: Smith Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, L.L.C
state: Oklahoma
city: Downingtown
country: United States
facility: Brandywine Clinical Research Center
state: Pennsylvania
city: Providence
country: United States
facility: Hypertension & Nephrology Inc
state: Rhode Island
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: IMED Research PA
state: Texas
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Madison
country: United States
facility: Gemini Scientific LLC
state: Wisconsin
Study officials:
affiliation: Ligand Pharmaceuticals
name: Rene Belder, MD
role: STUDY_DIRECTOR
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References: