Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00067041
NCT00067041TerminatedPhase 2

A Randomized Placebo-Controlled, 12-Week Multicenter Study of the Safety and Efficacy of Remodulin in Patients With Critical Limb Ischemia Following an Autogenous Vein Infrainguinal Bypass Graft

United Therapeutics4 sites in 1 country30 target enrollmentStarted: March 1, 2003Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
30
Locations
4
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Exclusion Criteria

  • Not provided

Investigators

Sponsor
United Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Completed
Phase 1
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DMType 1 Diabetes Mellitus
NCT02582840AstraZeneca42
Completed
Phase 3
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated ARRhinitis, Allergic, PerennialHouse Dust Mite Allergy
NCT02443805Stallergenes Greer1,607
Completed
Not Applicable
A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum DisorderAutism Spectrum Disorder
NCT02879110Central South University110
Not yet recruiting
Not Applicable
Peginterferon α-2b Combined CO2 Laser in Condylomata AcuminataCondylomata Acuminata
NCT06430190Zhangyu Bu30
Completed
Phase 4
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under BronchoscopyEndobronchial MetastasesBronchoesophageal FistulaGeneral Anesthetic Drug Adverse Reaction
NCT05468671Zhejiang Cancer Hospital34