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

November 9, 2007 updated by: United Therapeutics

Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve quality of life (QOL).

Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion. Ventavis (iloprost)is an inhaled prostacyclin analogue with similar properties to Remodulin. In December 2004, Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension (WHO Group I) for patients with NYHA III or IV symptoms.

As the PAH community gains experience with the use of inhaled Ventavis, questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patient's request related to dissatisfaction with the frequency of daily treatments. This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity, safety, HRQOL and treatment satisfactions.

Participation will last up to 12 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participates will have 4 clinic visits during the study and will spend at least one night in the hospital.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Medical Center Thornton Hospital
      • San Diego, California, United States, 92103
        • UCSD Medical Center Hillcrest Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;

Secondary Outcome Measures

Outcome Measure
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;
Score on treatment satisfaction scale;
Score on quality of life questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Therapeutics

Investigators

  • Principal Investigator: Hyong (Nick) Kim, MD, UCSD Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 6, 2007

First Posted (ESTIMATE)

April 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIV-PH-412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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