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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT00439946 |
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Date of registration:
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22/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
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Scientific title:
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Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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8 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00439946 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Remzi Bag, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INTEGRIS Baptist Medical Center |
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Name:
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Evelyn Horn, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Name:
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Teresa DeMarco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 to 65 years
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
1. Group 1 pulmonary arterial hypertension
- Idiopathic pulmonary arterial hypertension (IPAH)
- Familial pulmonary arterial hypertension (FPAH)
- Associated pulmonary arterial hypertension (APAH):
1. collagen vascular disease
2. congenital systemic-to-pulmonary shunt repaired greater than 5 years
prior to study entry.
3. portal hypertension
4. drugs and toxins
2. 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.
- Mentally and physically capable of learning to administer Remodulin using an
intravenous infusion pump.
Exclusion Criteria:
- 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):
1. Total Lung Capacity = 60% (predicted) or
2. 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.
- The presence of any physiological or psychological condition that contraindicates the
administration of Remodulin.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Device: Crono Five ambulatory pump
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Drug: treprostinil
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Primary Outcome(s)
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Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
[Time Frame: Week 8]
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Secondary Outcome(s)
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Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
[Time Frame: Week 8]
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Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
[Time Frame: Week 8]
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Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
[Time Frame: Week 8]
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Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
[Time Frame: Week 8]
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Change From Baseline at Week 8 in PAH Symptoms- Syncope
[Time Frame: Week 8]
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Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
[Time Frame: Week 8]
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Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test
[Time Frame: Week 8]
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Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
[Time Frame: Baseline and Week 8]
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Change From Baseline at Week 8 in PAH Symptoms- Dizziness
[Time Frame: Week 8]
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Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
[Time Frame: Baseline and Week 8]
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Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
[Time Frame: Week 8]
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Change From Baseline at Week 8 in Symptoms of PAH- Edema
[Time Frame: Week 8]
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Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
[Time Frame: Week 8]
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Secondary ID(s)
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RIV-PH-410
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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