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Pulmonary Arterial HypertensionPhase 4TRUST-1NCT00494533

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

A Phase 4 study testing Remodulin (treprostinil sodium) in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 14 sites in India.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Remodulin (treprostinil sodium)
How many people
45 participants
Where
14 sitesIndia
Study dates
Mar 2005to Oct 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
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  • 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 \&
  • evidence of normal LV function \&
  • absence of mitral valve stenosis.
  • Have chest radiograph consistent with PH performed in last 3 months. Radiograph must show clear lung fields or no more than patchy interstitial infiltrates.
  • Unless contraindicated, able to receive one of following anticoagulants: warfarin to achieve INR between 1.5-2.5 or heparin to produce aPTT between 1.3-1.5 times control, unless higher levels clinically indicated.
  • Mentally and physically capable of learning to administer Study Drug using ambulatory intravenous infusion pump and central venous access, or have trained caregiver.
  • If on corticosteroids, receiving stable dose of 20 mg/day of prednisone (or equivalent dose of another steroid) for at least 1 month prior to entry.

Who cannot join

  • 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):
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  • 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
  • LVEF < 40% by MUGA, angiography or echocardiography or
  • LV Shortening Fraction < 22% by echocardiography or
  • Symptomatic coronary disease (demonstrable ischemia).
  • Have any disease other than HIV or connective tissue disease associated with PH (e.g. sickle cell anemia, schistosomiasis).
  • Have active AIDS or tuberculosis.
  • Have musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease thought to limit ambulation, or connected to machine which is not portable.
  • Have baseline exercise capacity of <50 m or >325 m as measured by 6-Minute Walk Test.
  • Have uncontrolled systemic hypertension as evidenced by systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
  • Have used prescription appetite suppressants in 3 months of study entry.
  • Have chronic renal insufficiency defined by creatinine >2.5 mg/dL or requiring dialysis.
  • Receiving an investigational drug (other than acute challenge with epoprostenol), have in place an investigational device, or have participated in investigational drug/device study in past 30 days.
  • Have presence of any physiological or mental condition which contraindicates administration of Remodulin.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

India14 sites

  • SAL Hospital & Medical Institute

    Ahmedabad

  • Narayana Hrudayalaya Inst. Of Cardiac Sciences

    Bangalore

  • Apollo Hospitals

    Chennai

  • K. S. Hospital

    Chennai

  • Sri Ramachandra Medical College

    Chennai

  • Medwin Heart Institute

    Hyderabad

  • Yashoda Super Specialty Hospital

    Hyderabad

  • Apollo Gleneagles Hospital

    Kolkata

  • KMC Hospital

    Mangalore

  • Kasturba Medical College

    Manipal

  • KEM Hospital

    Mumbai

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

    New Delhi

  • Ruby Hall Clinic

    Pune

  • Krishna Institute of Medical Sciences

    Secunderabad

Other trials in India

About this study

Official title: Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension

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).

Being tested
Remodulin (treprostinil sodium)
Keywords
pulmonary arterial hypertension, prostacyclin analogue, intravenous
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remodulin (treprostinil sodium)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-minute walk distance

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

    Measured: Twelve Weeks

Secondary outcomes (5)

  1. Borg Dyspnea Score

    The Bord dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).

    Measured: Twelve Weeks

  2. Dyspnea-Fatigue Index

    The dyspnea-fatigue index was assessed at Baseline, Weeks 1, 4, 8 ans 12. Each of the three components of the dyspnea-fatigue index were rated on a scale of 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.

    Measured: Twelve weeks

  3. NYHA Functional Class

    Changes from Baseline in NYHA Functional Class will be summarized and compared between treatment groups at Weeks 1, 4, 8 and 12.

    Measured: Twelve Weeks

  4. Clinical Worsening

    Clinical worsening was defined as worsening PAH resulting in death, transplant, hospitalization, necessity to unblind for rescue therapy, or an inability to physically perform the walk assessment. Incidence of clinical worsening and the time from Baseline to clinical worsening will be compared between treatment groups.

    Measured: Twelve Weeks

  5. Combined Walk and Borg Dyspnea Score

    The intent of the Six-Minute Walk Test is to determine how much patients can do during the course of carrying out activities of daily living. However, the capacity of patients to function is determined not only by what they can do when they exert themselves to the fullest, but also by how they feel when they are carrying out their usual activities of daily living. It is therefore important not only to look at the distance traversed during the unencouraged 6-minute walk but also the symptoms experienced at the end of the effort. To do so, walk distances and Borg Scores from the Week 12 Six-Minute Walk Test were simultaneously compared between treatment groups.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2007 (estimated)
  2. Study startMar 2005
  3. Primary completionOct 2005
  4. Study completionOct 2005

Why it stopped: Safety issues related to outpatient intravenous infusion in India

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494533
Sponsor's protocol ID
RIV-PH-402
Acronym
TRUST-1
Status last verified
Jan 2014
First submitted
27 Jun 2007
Last updated
29 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20022264

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remodulin (treprostinil sodium) in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 14 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Safety issues related to outpatient intravenous infusion in India). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-minute walk distance (time frame: Twelve Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00494533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.

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