Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension

NCT00494533 | Terminated Phase 4 DMC

• 1 other identifier: RIV-PH-402
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 14

Brief Summary

Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension; prostacyclin analogue; intravenous

Outcome Measures

Primary Outcomes (1)

• Six-minute walk distance

  Placebo-corrected change in 6-minute walk distance from Baseline to Week 12.

  Twelve Weeks

Secondary Outcomes (5)

• Borg Dyspnea Score

  Twelve Weeks

• Dyspnea-Fatigue Index

  Twelve weeks

• NYHA Functional Class

  Twelve Weeks

• Clinical Worsening

  Twelve Weeks

• Combined Walk and Borg Dyspnea Score

  12 Weeks

Interventions

Remodulin (treprostinil sodium) DRUG

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 16- 75 years of age.
• Male or, if female, physiologically incapable of childbearing or utilizing birth control.
• Have current diagnosis of symptom-limited NYHA Functional Class III/IV PAH that is:
• PPH ("idiopathic" or familial PAH); or
• PAH associated with collagen vascular disease (confirmed by antinuclear antibody titer or acceptable test); or
• PAH associated with HIV infection (confirmed by serological test).
• If HIV positive, have CD4 lymphocyte count ≥ 200 at baseline and receiving current SOC anti-retroviral or effective medication for HIV infection.
• Optimally treated with conventional PH therapy and clinically stable for at least 1 month prior to baseline.
• Have ventilation/perfusion scan, contrast-enhanced CT scan, or pulmonary angiogram after onset of PAH that rules out pulmonary embolism.
• Have cardiac catheterization in last 3 months (or at Baseline) showing:
• PAPm \> 35 mmHg (at rest) \&
• PCWPm (or LV end diastolic pressure) \< 16 mmHg \&
• PVR \> 5 mmHg/L/min.
• Have echocardiogram in last 3 months consistent with PH, specifically:
• evidence of RV hypertrophy or dilation \&

You may not qualify if:

• Nursing or pregnant (women of childbearing potential have negative pregnancy test).
• Have had new type of chronic therapy (including but not limited to oxygen, different category of vasodilator, diuretic, digoxin) for PH, except for anticoagulants, added in last month.
• Be scheduled for heart-lung transplant.
• Have any PH medication except for anticoagulants discontinued in week prior to study entry.
• Have received any chronic prostaglandin or prostaglandin analogue (including intravenous/inhaled/oral: epoprostenol, iloprost, beraprost, etc.), any phosphodiesterase inhibitor therapy such as sildenafil, or any endothelin antagonist therapy such as bosentan, in past 30 days.
• Have PH associated with chronic thromboembolic disease; or chronic obstructive lung diseases or hypoxemia; or evidence of significant parenchymal lung disease as evidenced by PFTs in last 3 months as follows (any one of following):
• TLC \< 60% (predicted) or high resolution CT documenting diffuse interstitial fibrosis or alveolitis
• FEV1/FVC ratio \< 50%
• Have Portal Hypertension.
• Have history of uncontrolled Sleep Apnea, defined as oxygen desaturation less than 90% at night, in past 3 months.
• Have history of left-sided heart disease including:
• Aortic or mitral valve disease or
• Pericardial constriction or
• Restrictive or congestive cardiomyopathy; or have evidence of current left-sided heart disease defined by:
• PCWPm or LV end diastolic pressure \> 16 mmHg or

Sponsors & Collaborators

• United Therapeutics: lead
• Asian Clinical Trials: collaborator

Study Sites (14)

SAL Hospital & Medical Institute

Ahmedabad, India

Location

Narayana Hrudayalaya Inst. Of Cardiac Sciences

Bangalore, India

Location

Apollo Hospitals

Chennai, India

Location

K. S. Hospital

Chennai, India

Location

Sri Ramachandra Medical College

Chennai, India

Location

Medwin Heart Institute

Hyderabad, India

Location

Yashoda Super Specialty Hospital

Hyderabad, India

Location

Apollo Gleneagles Hospital

Kolkata, India

Location

KMC Hospital

Mangalore, India

Location

Kasturba Medical College

Manipal, India

Location

KEM Hospital

Mumbai, India

Location

G. B. Pant Hospital & Maulana Azad Med. College

New Delhi, India

Location

Ruby Hall Clinic

Pune, India

Location

Krishna Institute of Medical Sciences

Secunderabad, India

Location

Related Publications (1)

• Hiremath J, Thanikachalam S, Parikh K, Shanmugasundaram S, Bangera S, Shapiro L, Pott GB, Vnencak-Jones CL, Arneson C, Wade M, White RJ; TRUST Study Group. Exercise improvement and plasma biomarker changes with intravenous treprostinil therapy for pulmonary arterial hypertension: a placebo-controlled trial. J Heart Lung Transplant. 2010 Feb;29(2):137-49. doi: 10.1016/j.healun.2009.09.005.

  PMID: 20022264 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Wade, Ph.D.

  United Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 29, 2007
• Study Start: March 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

IN (14)