Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure

NCT00651885 | Completed Phase 2

• 1 other identifier: 2006.219.B
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a last resort where limb salvage cannot be achieved. Despite the success of percutaneous intervention for small coronary vessels with lumen diameters less than 3 mm, similar techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and restenosis in as many as 50% of treated patients. As a result of the limited success, these percutaneous procedures have been reserved for the severest cases whereby limb loss is imminent without intervention. In this context, the sickest of all patients are enrolled in these trials and poor outcomes are common regardless of the intervention. Agents that promote intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet aggregation. These properties suggest that prostacyclin analogues such as treprostinil will be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of patients with CLI that can benefit from peripheral endovascular intervention. An orally available prostacyclin analogue could represent an important treatment advance in the prevention of restenosis following infrapopliteal angioplasty. In the present study, the safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo in patients with CLI undergoing an infra-popliteal endovascular intervention.

Conditions

Critical Limb Ischemia

Keywords

UT-15C; Peripheral Vascular Disease; Treprostinil

Outcome Measures

Primary Outcomes (1)

• To assess the tolerability and safety of UT-15C SR as compared to placebo tablets in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.

  12 weeks

Secondary Outcomes (1)

• To assess the efficacy of UT-15C SR as compared to placebo tablets on measures of clinical outcomes in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.

  12-52 weeks

Study Arms (2)

2 arm

PLACEBO COMPARATOR

Drug: Placebo

1 arm

EXPERIMENTAL

treprostinil dienthalomine

Drug: treprostinil dienthanolmine sustained release

Interventions

treprostinil dienthanolmine sustained release DRUG

UT-15C SR 1mg tablet

Also known as: UT-15C SR

1 arm

Placebo DRUG

Placebo

2 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 or older.
• Have an anticipated infra-popliteal endovascular intervention.
• Have a diagnosis of stage IIb- IVa (Fontaine) or stage 3- 5 (Rutherford scale) CLI due to documented peripheral arterial disease (Appendix E)
• If female, be physiologically incapable of childbearing or practicing acceptable methods of birth control.
• Have signed an appropriate informed consent for participation in this study.

You may not qualify if:

• Have had a previous endovascular intervention or stenting on the target limb.
• Be hemodynamically unstable, on hemodialysis for end stage renal failure, or have acute renal, cardiac or pulmonary failure.
• Have a history of intracranial bleeding, bleeding ulcer, urinary tract bleeding; or bleeding due to significant trauma within six weeks prior to study entry.
• Have a life-threatening malignancy requiring aggressive chemotherapy.
• Have any condition or laboratory value which, based on information in the UT-15C SR investigators' brochure, would constitute an unacceptable risk to the patient's safety, in the opinion of the investigator.
• Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial.
• Have a known hypersensitivity to prostacyclin.
• Have participated in any investigational trial within 30 days of study drug initiation.
• Have been a non-responder to chronic (\>30 days) prostanoid treatment, or have completed a chronic trial of prostanoid therapy within 30 days of study drug initiation.
• Be a pregnant or nursing woman.

Sponsors & Collaborators

• Ochsner Health System: lead
• United Therapeutics: collaborator

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Mark A Grise, M.D.

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

US (1)