Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

NCT00439946 | Terminated Phase 4 Results

• 1 other identifier: RIV-PH-410
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension; PAH; Remodulin; treprostinil; Quality of Life; rapid switch

Outcome Measures

Primary Outcomes (1)

• Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)

  The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site \[American Thoracic Society (ATS) guidelines; 2002\].

  Week 8

Secondary Outcomes (13)

• Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test

  Week 8

• Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification

  Week 8

• Change From Baseline at Week 8 in Symptoms of PAH- Fatigue

  Week 8

• Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea

  Week 8

• Change From Baseline at Week 8 in Symptoms of PAH- Edema

  Week 8

Study Arms (1)

treprostinil

EXPERIMENTAL

IV treprostinil continuous infusion via Crono Five infusion pump.

Drug: treprostinil; Device: Crono Five ambulatory pump

Interventions

treprostinil DRUG

rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump

Also known as: Remodulin

treprostinil

Crono Five ambulatory pump DEVICE

Used for administration of IV Remodulin (treprostinil)

treprostinil

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65 years
• Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
• Group 1 pulmonary arterial hypertension
• Idiopathic pulmonary arterial hypertension (IPAH)
• Familial pulmonary arterial hypertension (FPAH)
• Associated pulmonary arterial hypertension (APAH):
• collagen vascular disease
• congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry.
• portal hypertension
• drugs and toxins
• Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
• WHO Class II-III
• Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
• Have central intravenous catheter
• Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.

You may not qualify if:

• nursing or pregnant woman
• received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month.
• Had any PAH medication discontinued within the week prior to study entry.
• Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
• Had a central venous line infection within the past 30 days.
• Previous documented evidence of significant parenchymal lung disease as evidenced by pulmonary function tests as follows (any one of the following):
• Total Lung Capacity ≤ 60% (predicted) or
• If Total Lung Capacity is between 60% and 70% (predicted), a High Resolution Computed Tomography (CT) scan must be performed to rule out diffuse interstitial fibrosis or alveolitis
• History of or evidence of left-sided heart disease
• Having any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
• Having a 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 as evidenced by a systolic blood pressure greater than 160 millimeters of mercury (mmHg) or diastolic blood pressure greater than 100 mmHg.
• Chronic renal insufficiency as defined by serum creatinine greater than 2.5 milligrams per deciliter (mg/dL) or the requirement for dialysis.
• Receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
• Active infection, or any other ongoing condition that would interfere with the interpretation of study assessments.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (3)

University of California San Francisco (UCSF) Medical Center

San Francisco, California, 94143, United States

Location

THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73122, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Interventions

treprostinil

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The main limitations of this study are the modest sample size and relatively short duration of follow-up.

Results Point of Contact

• Title: Remodulin Program Leader
• Organization: United Therapeutics

ClinicalRecordsManagement@unither.com

(919) 485-8350

Study Officials

• Remzi Bag, MD

  INTEGRIS Baptist Medical Center

  PRINCIPAL INVESTIGATOR

• Evelyn Horn, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Teresa DeMarco, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2011
• Last Updated: January 3, 2024
• Results First Posted: July 17, 2013

Record last verified: 2013-06

Locations

US (3)