Extended-release tacrolimus for pulmonary arterial hypertension with ongoing physical limitations
Tests extended-release tacrolimus against placebo in adults with pulmonary arterial hypertension despite treatment.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
Key facts
- Where
- Barcelona, Lugo, Madrid, Marbella, Toledo, and Vigo, SpainSee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07612657, who can take part
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainNot yet recruiting
- Hospital Universitario Lucus AugustiLugo, SpainNot yet recruiting
- Hospital Universitario 12 de OctubreMadrid, SpainNot yet recruiting
- Hospital Universitario Ramón y CajalMadrid, SpainNot yet recruiting
- Hospital Costa del SolMarbella, SpainNot yet recruiting
- Hospital Universitario de ToledoToledo, SpainNot yet recruiting
- Hospital Alvaro CunqueiroVigo, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VIVUS LLC
- Trial code
- NCT07612657EU 2025-524596-24-00
- Record updated
- 29 May 2026
- Original description
This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications
This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.
Inclusion: WHO Group 1 PH: Pulmonary Arterial Hypertension; WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening; Right heart catheterization (RHC) at screening (or within 3 months prior to screening); Screening 6MWD >75 meters to ≤450 meters.
Exclusion: Current systemic treatment with cyclosporine; PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis; Chronic thromboembolic or portopulmonary hypertension; Evidence of left-sided heart disease; Active infection requiring antibiotic, antifungal, or antiviral therapies; Known allergy or hypersensitivity to tacrolimus; Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment; eGFR <30 mL/min/1.73 m2 (CKD-EPI equation); Serum potassium >5.1 mEq/L; Total Lung Capacity (TLC) <60% predicted; FEV1/FVC <70% predicted or FEV1 <60% predicted; Inability to safely attempt completion of the 6MWD; Life expectancy <6 months; Moderate to severe hepatic dysfunction (Child-Pugh score >10); Use of experimental PAH treatments within the past 3 months.