|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00458042 |
|
Date of registration:
|
05/04/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction
|
|
Scientific title:
|
Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction |
|
Date of first enrolment:
|
March 2007 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00458042 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Hyong (Nick) Kim, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UCSD Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension, Pulmonary
|
|
Intervention(s)
|
|
Drug: treprostinil sodium
|
|
Primary Outcome(s)
|
|
Adverse events
|
|
Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;
|
|
Secondary Outcome(s)
|
|
Specific prostacyclin side effects;
|
|
Score on treatment satisfaction scale;
|
|
Secondary Outcomes: Borg dyspnea score immediately after the six minute walk test;
|
|
Score on quality of life questionnaire
|
|
Symptoms of PAH;
|
|
WHO functional classification;
|
|
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;
|
|
Secondary ID(s)
|
|
RIV-PH-412
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|