Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension
1 other identifier
interventional
162
9 countries
54
Brief Summary
This Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study will compare the efficacy, safety, and tolerability of cicletanine hydrochloride (HCl) to placebo in subjects with PAH. Study drug will be administered alone, or on the background of stable PAH therapy. The study will consist of 3 periods: a screening period, a 12-week placebo-controlled treatment period, and a long-term, blinded extension period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2009
Typical duration for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 4, 2014
January 1, 2014
2.7 years
January 29, 2009
January 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
Baseline to Week 12
Secondary Outcomes (1)
Change from baseline in BDI, WHO Functional Class, BNP, cardiac hemodynamics and SF-36 physical functioning scale following 12 weeks of treatment. In addition, time to clinical worsening (TTCW) will be evaluated.
Baseline to Week 60
Study Arms (4)
Cicletanine 150 mg QD
EXPERIMENTALCicletanine 150 mg administered once daily (QD)
Cicletanine 150 mg BID
EXPERIMENTALCicletanine 150 mg administered twice daily (BID)
Cicletanine 300 mg QD
EXPERIMENTALCicletanine 300 mg administered once daily (QD)
Placebo
PLACEBO COMPARATORPlacebo to match cicletanine administered once daily
Interventions
Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily
Placebo to match cicletanine administered orally once daily, followed by active cicletanine in the blinded extension period
Eligibility Criteria
You may qualify if:
- Between 16 and 70 years of age
- 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
- +6 more criteria
You may not qualify if:
- Subject with a current PH diagnosis other than IPAH, FPAH, or PAH that is primarily due to: Connective tissue disease, Congenital heart defects, Drug and toxin use, or HIV infection
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (56)
University of South Alabama
Mobile, Alabama, 36617, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, 85013, United States
VA Greater LA Healthcare System
Los Angeles, California, 90073, United States
University of California San Diego Medical Center
San Diego, California, 92037, United States
Harish H. K. Murthy, MD
San Jose, California, 95124, United States
UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Cleveland Clinic
Fort Lauderdale, Florida, 33331, United States
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Cornell University
New York, New York, 10021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14623, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
Case Medical Center
Cleveland, Ohio, 44106, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210-1252, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
University Of Virginia
Charlottesville, Virginia, 22908, United States
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
University Klinik Graz
Graz, 8036, Austria
University Klinik Wien
Vienna, 1090, Austria
ULB Hôpital Erasme
Brussels, 1070, Belgium
Peter Lougheed Centre
Calgary, Alberta, T1Y6J4, Canada
London Health Sciences Centre
London, Ontario, N6A5W9, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Ludwig-Maximilians-Universitaet
Munich, Bavaria, 80336, Germany
Universitaetsklinikum Giessen und Marburg
Giessen, Hesse, 35392, Germany
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Unidad de Investigación Clínica en Medicina S.C.
Monterrey, Nuevo León, 64718, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Mexico
H Clinic i Provincial
Barcelona, 8036, Spain
HU 12 de Octubre
Madrid, 28041, Spain
Royal Free Hospital
London, Gt Lon, NW32QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gennyne Walker, PhD
Senior Clinical Research Scientist, Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
January 1, 2009
Primary Completion
October 1, 2011
Study Completion
March 1, 2012
Last Updated
February 4, 2014
Record last verified: 2014-01