Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction

NCT00458042 | Terminated Phase 4

• 1 other identifier: RIV-PH-412
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.

Conditions

Hypertension, Pulmonary

Keywords

Ventavis; iloporst; Remodulin; treprostinil; PAH; prostacyclin

Outcome Measures

Primary Outcomes (2)

• Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;

• Adverse events

Secondary Outcomes (7)

• Secondary Outcomes: Borg dyspnea score immediately after the six minute walk test;

• WHO functional classification;

• Symptoms of PAH;

• Specific prostacyclin side effects;

• Total weekly time spent with specific activities associated with intravenous Remodulin therapy compared to the total weekly time spent on specific activities with inhaled Ventavis;

Interventions

treprostinil sodium DRUG

Eligibility Criteria

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

You may qualify if:

• Be between 18 years and 65 years of age
• WHO Class II-III
• Diagnosis of one of the following Group I WHO clinical classifications: Idiopathic or familial pulmonary arterial hypertension (PAH) or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction or PAH associated with drugs or toxins.
• Receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
• May have discontinued iloprost treatment against medical advice up to thirty days prior to screening
• Be mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.

You may not qualify if:

• Be a nursing or pregnant woman
• Have any PAH medication, other than inhaled iloprost, discontinued within the week prior to study entry.
• Received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
• Previous history of significant parenchymal lung disease
• Have any other type of PAH including but not limited to PAH related to thrombotic or embolic disease
• Have evidence of left-sided heart disease
• Musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
• Uncontrolled systemic hypertension or chronic renal insufficiency
• Use of an investigational drug within the past 30 days.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (2)

UCSD Medical Center Thornton Hospital

La Jolla, California, 92037, United States

Location

UCSD Medical Center Hillcrest Campus

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hyong (Nick) Kim, MD

  UCSD Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 9, 2007
• Study Start: March 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 12, 2007

Record last verified: 2007-11

Locations

US (2)