Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID: NCT00832507
Run by: Gilead Sciences
People needed: 162
Starts: 2009-01-01
Expected to finish: 2012-03-01
Last updated by the study team: 2014-02-04

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
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

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
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

Where it is running

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
University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.