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NCT03626688 (Ralinepag in Pulmonary Arterial Hypertension): BVCT ex-ante prediction vs. reported outcome

On 9 May 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 2 Mar 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT03626688
Acronym
ADVANCE OUTCOMES
Drug Name
Ralinepag
Drug MoA
oral selective IP prostacyclin receptor agonist
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Arterial Hypertension (PAH)
Human Patients
687
Sponsor
United Therapeutics
Phase
Phase 3

Prediction of , index 1102

Prospective Prediction
Prediction Index
1102
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
1028 days in advance
Readout Data Interpretation
ralinepag achieved statistically significant placebo-adjusted 6MWD improvement (no data disclosed), which is probably inferior to 66m placebo-adjusted 6MWD improvement by the IV Epoprostenol at week 12 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
Phase
Phase 3
Status
Completed
Enrollment
687
Lead sponsor
United Therapeutics
Conditions
PAH; Pulmonary Hypertension; Pulmonary Arterial Hypertension; Hypertension; Connective Tissue Diseases; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Disease
Interventions
DRUG: Ralinepag; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-01-24
Primary completion
2025-12-31
Completion
2025-12-31
Primary outcomes
  • Time from randomization to the first adjudicated protocol-defined clinical worsening event (The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years)

NCT03626688 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials