Treprostinil Combined With Tadalafil for Pulmonary Hypertension
Public ClinicalTrials.gov record NCT01302444. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Objectives: To test whether the combined administration of the medications treprostinil(a prostacycline therapy), and tadalafil(a PDE-5 \[ phosphodiesterase type 5\]Inhibitor therapy) is better than the administration of treprostinil alone. This treatment would be offered to newly diagnosed patients with pulmonary arterial hypertension who are on no treatment for this disease and are deemed candidates for the medication treprostinil by their physician. The combination therapy will be compared to single therapy with only treprostinil in a double-blind manner. Current therapy is to begin one treatment, either a PDE5 inhibitor or a prostacycline, depending on the severity of the patient's PAH (pulmonary arterial hypertension) disease and add additional therapies as deterioration occurs. This treatment could add two agents initially. Secondary objectives are: To improve pulmonary arterial pressures as measured through a cardiac echocardiogram, improve the subject's 6minute walk distance, delaying the time to clinical worsening, and lowering plasma BNP levels. Research Procedures: To begin the administration of both treatments at the same time. Time period is 16 weeks with a one- year follow-up. Cardiac Echocardiograms, clinic physician exams, and lab work will be followed. Subjects will be between the ages of 18 - 75.
Study identification
- NCT ID
- NCT01302444
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2011
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
- Last update posted
- Jul 25, 2013
2011 – 2012
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | — |
| Tuft's New England Medical Center | Boston | Massachusetts | 02111 | — |
| Brigham & Womens Hospital | Boston | Massachusetts | 02115 | — |
| Saint Barnabas Health Care System, Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Weill Cornell Medical Center | New York | New York | 10021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01302444, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2013 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01302444 live on ClinicalTrials.gov.