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Remodulin Medical Research Studies

Up-to-date List of Remodulin Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Remodulin Medical Research Studies

Rank Status Study
1 Recruiting Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: inhaled prostacyclin;   Drug: prostacyclin;   Drug: subcutaneous and intravenous prostacyclin;   Drug: oral ERA;   Drug: oral PDE5 inhibitors
Outcome Measures: Describe the type and incidence of oro-/nasopharyngeal and pulmonary adverse events that may be associated with current or recent treatment with Tyvaso for PAH;   Compare the incidence of selected oro-/nasopharyngeal and pulmonary adverse events in patients treated with Tyvaso for PAH with patients not treated with Tyvaso for PAH
2 Unknown  Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: HypotonicTreprostinil Solution;   Drug: Eutonic Treprostinil Solution
Outcome Measures: Daily Pain Diary;   McGill Pain Questionnaire;   CAMPHOR quality of life questionnaire;   6 minute walk distance;   NT-proBNP level
3 Recruiting Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation
Condition: Ischemia Reperfusion Injury
Intervention: Drug: Treprostinil
Outcome Measures: Serum ALT concentration after treprostinil treatment in liver transplant patients;   Pharmacokinetics of treprostinil in liver transplant patients
4 Recruiting Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension
Condition: Congenital Heart Disease
Intervention: Drug: Remodulin
Outcome Measures: Improved cardiopulmonary exercise test;   Improved overall cardiopulmonary variables
5 Unknown  UT-15C SR in the Treatment of Critical Limb Ischemia
Condition: Critical Limb Ischemia
Intervention: Drug: UT-15C SR (treprostinil diethanolamine) 1mg oral tablets
Outcome Measures: To assess the tolerability and safety of UT-15C tablets in subjects with critical limb ischemia (CLI) and ischemic rest pain;   To assess the effect of UT-15C on the following disease symptoms associated with CLI:;   ž Ischemic rest pain;   ž Sleep interference;   ž Ambulatory status;   ž Ischemic wound healing (if applicable);   To obtain peak and trough treprostinil plasma levels in CLI subjects
6 Recruiting Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Conditions: Pulmonary Hypertension;   COPD
Intervention: Drug: Inhaled Treprostinil Therapy
Outcome Measures: To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).;   New York Heart Association (NYHA) functional class;   Six minute walk distance;   Clinical Worsening;   Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression;   St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire
7 Unknown  The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Conditions: Pulmonary Hypertension;   Pulmonary Arterial Hypertension
Intervention: Drug: Qutenza (8% capsaicin)
Outcome Measures: Pain score on a visual analogue scale;   Pain associated with Qutenza patch application;   Use of narcotics following a treprostinil infusion site change
8 Recruiting Study Of Right Ventricular Performance In PAH Patients Treated With Rapid Dose Treprostinil (Remodulin)
Condition: Pulmonary Arterial Hypertension
Intervention:
Outcome Measure: Measurement of change in RV coupling index on treprostinil between baseline, titration at 48-72 hours, and 3 months.
9 Recruiting An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: UT-15C (treprostinil diethanolamine)
Outcome Measure: Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline)
10 Recruiting Trial of the Early Combination of Oral Treprostinil With a PDE-5 Inhibitor or ERA in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: UT-15C (treprostinil diethanolamine);   Drug: Placebo
Outcome Measures: Change in 6 minute walk distance;   Time to first clinical worsening event
11 Not yet recruiting Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers
Condition: PAH
Intervention: Drug: TransCon PEG treprostinil
Outcome Measures: Incidence of treatment-emergent AEs;   Maximum tolerated dose;   Treatment-emergent changes in clinical laboratory results;   Treatment-emergent changes in vital signs;   Area under the concentration versus time curve: (AUC);   Maximum observed plasma concentration: Cmax;   Time to maximum observed plasma concentration: Tmax
12 Recruiting Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching
Conditions: Pulmonary Arterial Hypertension;   Chronic Obstructive Pulmonary Disease
Intervention:
Outcome Measures: Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.;   Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
13 Recruiting Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Condition: Non-operable Chronic Thromboembolic Pulmonary Hypertension
Intervention: Drug: Treprostinil sodium
Outcome Measures: To determine the effect of subcutaneous Treprostinil sodium on 6MWT distance after 24 weeks in patients with severe non-operable chronic thromboembolic pulmonary hypertension severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension;   To assess the time to clinical worsening;   To assess the effect on maximal Borg score, heart rate and oxygen saturation during 6MWT;   To assess the effect on WHO NYHA (World health organization- New York Heart Association) functional class;   To assess the effect on QOL (Quality of Life) by the MINNESOTA questionnaire;   To assess the effect on N-terminal pro-BNP levels;   To assess the effect on hemodynamic parameters (PVR, mPap, mRap (Mean right atrial pressure, SVR (Systemic Vascular Resistance), CO (Cardiac Output), CI (Cardiac Index));   To assess the effect on signs & symptoms of the CTEPH;   To assess the treatment - emergent Adverse Events (AE's), Serious Adverse Events (SAE's) , AE's leading to discontinuation and relevant laboratory abnormalities
14 Unknown  Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension
Conditions: Pulmonary Arterial Hypertension;   Interstitial Lung Disease;   Idiopathic Pulmonary Fibrosis
Intervention: Drug: treprostinil
Outcome Measures: 6 minute walk distance;   Hemodynamic parameters;   Quality of life and shortness of breath indices
15 Recruiting Beraprost-314d Added-on to Tyvaso® (BEAT)
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Beraprost Sodium 314d Modified Release Tablets;   Drug: Placebo
Outcome Measures: Time to clinical worsening defined as time from randomization to the first of any of the events described below.;   6 minutes Walk Distance;   Borg Dyspnea Score;   WHO Functional Class;   NT-pro-BNP levels;   Safety will be assessed by adverse events, physical examination, vital signs, clinical laboratory parameters, and electrocardiogram findings.
16 Unknown  Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension
Conditions: Pulmonary Hypertension;   End-Stage Renal Disease;   Hemo-dialysis Therapy
Intervention:
Outcome Measure:
17 Recruiting COMPERA / COMPERA-KIDS
Conditions: Pulmonary Arterial Hypertension (PAH);   Pulmonary Hypertension (PH)
Intervention:
Outcome Measure:
18 Recruiting LenusPro Safety (LPS) Study in Patients With PH
Condition: Pulmonary Hypertension
Intervention: Other: PH patients with LenusPro pump
Outcome Measures: Measurement of numbers of predefined complications in longterm treatment with LenusPro medication pump;   Measurement of catheter (or pump) complications;   Measurement of numbers of predefined refill complications
19 Recruiting A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Ranolazine;   Drug: Placebo
Outcome Measures: Change in pulmonary vascular resistance (PVR);   Change in CPET (VE/VCO2, PETCO2, peak VO2, peak HR, peak RER, work max (MET or Watt), sub maximum exercise time;   Change in RV echo parameters: 2D, 3D;   Change in 6MWD;   Safety/SAE
20 Not yet recruiting Endothelial Function in Patients With Scleroderma or Cirrhosis With and Without Pulmonary Hypertension
Condition: Pulmonary Hypertension
Intervention:
Outcome Measure: Base Line

These studies may lead to new treatments and are adding insight into Remodulin etiology and treatment.

A major focus of Remodulin research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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