Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00832507
Last Updated: 2014-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
162 participants
INTERVENTIONAL
2009-01-31
2012-03-31
Brief Summary
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Detailed Description
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The secondary objectives of this study are:
1. To compare the change in other clinical measures of PAH following treatment with cicletanine HCl or placebo in subjects with PAH
2. To compare the safety and tolerability of cicletanine HCl to placebo in subjects with PAH Additionally, the long-term safety, tolerability, and efficacy of cicletanine HCl treatment will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cicletanine 150 mg QD
Cicletanine 150 mg administered once daily (QD)
Cicletanine
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Cicletanine 150 mg BID
Cicletanine 150 mg administered twice daily (BID)
Cicletanine
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Cicletanine 300 mg QD
Cicletanine 300 mg administered once daily (QD)
Cicletanine
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Placebo
Placebo to match cicletanine administered once daily
Cicletanine
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Cicletanine Placebo
Placebo to match cicletanine administered orally once daily, followed by active cicletanine in the blinded extension period
Interventions
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Cicletanine
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Cicletanine Placebo
Placebo to match cicletanine administered orally once daily, followed by active cicletanine in the blinded extension period
Eligibility Criteria
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Inclusion Criteria
* Weigh greater than or equal to 40 kg
* Have a current diagnosis of IPAH, FPAH, or PAH that is primarily due to: connective tissue disease, congenital heart defects, drug and toxin use, and HIV infection
* Meet all of the following hemodynamic criteria by means of a RHC completed prior to or during Screening: mPAP of greater than or equal to 25 mmHg, PVR greater than 240 dyne.sec/cm5, PCWP or LVEDP of less than or equal to1 5 mmHg
* Walk a distance of at least 100 m but no more than 450 m during the screening 6MWT
* Have WHO functional class II, III, or IV symptoms
* Meet all of the following pulmonary function tests completed no more than 12 weeks before the Screening visit: TLC greater than or equal to 60% of predicted normal \& FEV1 greater than or equal to 65% of predicted normal, FEV1:FVC ratio greater than 0.60
* Have laboratory results within 90% of the lower limit of normal to 1.5 times the upper limit of normal
* Receiving treatment with an approved ERA, PDE5i, and/or parenteral prostanoid must be receiving this therapy for greater than or equal to 12 weeks prior to the Screening Visit and must be at a stable dose for greater than or equal to 4 consecutive weeks prior to the Screening Visit.
* Eligible therapies allowed at Screening include:a. Monotherapy with an ERA, PDE5i, or parenteral prostanoid that is approved for the treatment of PAH b. Combination therapy with two eligible PAH treatments (any combination of ERA, PDE5i, or parenteral prostanoid
* Subject receiving diuretic treatment must be on stable therapy
* If receiving digitalis, CCBs, angiotensin receptor blockers (ARBs), angiotensin converting enzyme (ACE) inhibitors, or beta-blocking agents subject must be on stable therapy
* If receiving HMG-CoA reductase inhibitors, subject must be on stable therapy
* If diagnosis of HIV subject must have stable disease status
* Female subjects of childbearing potential must have a negative serum pregnancy test
* Female subjects of childbearing potential must agree to use 2 reliable methods of contraception
* Must agree not to participate in a clinical study involving another investigational drug or device
* Must be competent to understand and sign the IRB approved ICF
* Has not enrolled in an exercise training program for pulmonary rehabilitation and must agree not to enroll in an exercise training program for pulmonary rehabilitation
* If subject has been enrolled in an exercise training program for pulmonary rehabilitation for greater than 12 weeks prior to the Screening Visit and must agree to maintain their current level of rehabilitation for the first 12 weeks of the study
* Must be on background PAH therapy at Screening unless the subject does not have access to or can not tolerate currently approved PAH medical therapies
Exclusion Criteria
* Subject with LVEF less than or equal to 40% or clinically significant ischemic, valvular, or constrictive heart disease
* Subject with WHO functional class I symptoms
* Subject has chronically received an ineligible PAH treatment regimen within the 4 weeks prior to the Screening Visit, specifically: a. inhaled iloprost or inhaled treprostinil, b. combination treatment with three PAH therapies, c.any investigational therapy for the treatment of PAH d.Chronic use is considered greater than 7 consecutive days of treatment
* Subject receiving iv inotropes within 2 weeks prior to the Screening Visit
* Subject with SBP greater than or equal to 150 mmHg or less than 90mmHg
* Subject with moderate to severe liver disease
* Subject with moderate or severe renal impairment
* Subject receiving lithium within the 2 weeks prior to the Screening Visit
* Subject requiring intermittent or chronic treatment with nitrates
* Subject receiving non-anti-arrhythmic drugs
* Subject has a diagnosis of long QT syndrome
* Subject with evidence of chronic thromboembolic disease
* Subject with obstructive lung disease
* Subject with severe arthritis, musculoskeletal problems, or morbid obesity that would affect the subject's ability to perform or complete the 6MWT
* Has a history of malignancies within the past 5 years
* Subject with disease that may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject
* Female subject who is pregnant or breastfeeding
* Has demonstrated noncompliance with previous medical regimens
* Has a recent history of abusing alcohol or illicit drugs
* Has participated in a clinical study involving another investigational drug or device within 4 weeks before the Screening Visit
* Has a known hypersensitivity to the study drug, the metabolites, or formulation excipients
* Receiving an oral arginine supplement within 2 weeks prior to the Screening Visit
16 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gennyne Walker, PhD
Role: STUDY_CHAIR
Senior Clinical Research Scientist, Gilead Sciences
Locations
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University of South Alabama
Mobile, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
VA Greater LA Healthcare System
Los Angeles, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Harish H. K. Murthy, MD
San Jose, California, United States
UCLA Medical Center
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Cleveland Clinic
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Louisiana State University
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Tufts-New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Beth Israel Medical Center
New York, New York, United States
Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Case Medical Center
Cleveland, Ohio, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University Of Virginia
Charlottesville, Virginia, United States
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
University Klinik Graz
Graz, , Austria
University Klinik Wien
Vienna, , Austria
ULB Hôpital Erasme
Brussels, , Belgium
Peter Lougheed Centre
Calgary, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Ludwig-Maximilians-Universitaet
Munich, Bavaria, Germany
Universitaetsklinikum Giessen und Marburg
Giessen, Hesse, Germany
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Unidad de Investigación Clínica en Medicina S.C.
Monterrey, Nuevo León, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, , Mexico
H Clinic i Provincial
Barcelona, , Spain
HU 12 de Octubre
Madrid, , Spain
Royal Free Hospital
London, Gt Lon, United Kingdom
Countries
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Other Identifiers
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GS-US-235-0101
Identifier Type: -
Identifier Source: org_study_id
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