An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

This study has been terminated.

Sponsor:

Information provided by:

Epix Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00677872

First received: May 13, 2008

Last updated: July 28, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 13, 2008
Last Updated Date	July 28, 2009
Start Date ^ICMJE	May 2008
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 14, 2008)	Six-minute walk test (6-MWT)and mean pulmonary artery pressure (MPAP) utilizing right heart catheterization.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00677872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 14, 2008)	Central hemodynamic and exercise capacity parameters utilizing RHC and CPET
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
Official Title ^ICMJE	Not Provided
Brief Summary	A 3-month open label study to evaluate the safety and efficacy of PRX-08066 in patients with pulmonary hypertension and COPD.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	COPD Pulmonary Hypertension
Intervention ^ICMJE	Drug: PRX-08066
Study Arm (s)	Experimental: 1 Intervention: Drug: PRX-08066
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	40
Completion Date	Not Provided
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Men and Women >40 years of age Diagnosis of COPD with an FEV1 above 20% and less than 65% of predicted normal and an FEV1-to-FVC ratio of less than 70% Diagnosis of pulmonary hypertension based on echocardiography within the last 6 months or by cardiac catheterization within the last 12 months New York Heart Association(NYHA)Class II or III Screening LVEF>55%, obtained by any appropriate method within 6 months of screening Baseline 6MWT distance>150m and <450m Written informed consent from each subject prior to the initiation of any study-related procedure Documented negative results (within 12 months)and Hepatitis B and Hepatitis C Serology Exclusion Criteria: Treatment for pulmonary hypertension with epoprostenol (prostacyclin), trepostinil (Remodulin), iloprost (Ventavis), bosentan (Tracleer), ambrisentan (Letairis), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) within the 30 days prior to study entry Presence or history of any of the following cardiovascular co-morbidities or conditions: Un-controlled systemic hypertension at screening; unstable cardiovascular disease including intermittent atrial fibrillation or unstable angina within the 4 weeks prior to screening; amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous cardiac intervention within the 3 months prior to screening; significant valvular heart disease; cerebrovascular accident or transient ischemic attack within 3 months prior to screening COPD exacerbation less than 1 month prior to screening Exercise tolerance limited by non-cardiac causes Clinically significant psychiatric, addictive, neurologic disease or condition Chronic renal impairment or renal insufficiency No clinically significant laboratory abnormalities Subjects currently being treated for PH with prostnoids, PDE-5 inhibitors and or endothelin receptor antagonist. The use of PDE-5 inhibitors "as needed" for erectile dysfunction is acceptable as long as the subject does not take the medication within 72 hours of an efficacy assessment. Other concomitant medications are allowed provided the subject has been on a stable dose regimen for at least 4 weeks prior to enrollment and the regimen continues and remains stable during the treatment and follow-up periods. History of nasal airway mass, septal perforation, chronic sinusitis, lidocaine allergy or current nasal passage condition that would decrease the safety or tolerability of a naso-esophageal catheter The subject has the presence, or history, of malignancy that required significant medical intervention within the preceding 3 months and/or is likely to result in death within the next 2 years The receipt of any investigational medication within 30 days prior to screening or anytime during the course of the study Women cannot be pregnant or breastfeeding
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00677872
Other Study ID Numbers ^ICMJE	PRX-08066-202
Has Data Monitoring Committee	Not Provided
Responsible Party	Elkan Gamzu, PhD, EPIX Pharmaceuticals, Inc.
Study Sponsor ^ICMJE	Epix Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Epix Pharmaceuticals, Inc.
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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