Trial NCT02060487

View at ClinicalTrials.gov 
Org. Study IDs: A1481324
Secondary IDs: 2013-004362-34 AFFILIATE

Last trial update was posted on 2022-05-13

MeSH Interventions

Citric Acid Sildenafil Citrate Sodium Citrate

MeSH Conditions

Familial Primary Pulmonary Hypertension Hypertension Pulmonary Arterial Hypertension

Other Conditions


Stopping Reasons

Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.

Limitations And Caveats

Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met. For OS and clinical worsening(CW) endpoints, significance level was adjusted to allow for interim analysis. Hence 99.7% CIs were presented instead of 95% CIs. 80mg vs 5mg comparison for OS was primary and it was key secondary for CW. CIs for other dose comparisons for these endpoints were nominal. P-values and CIs for other endpoints were nominal

Result Publications

N/A

Annotations

Category Annotations
No annotators decided on categories yet

Intervention Annotations
# Outdated Intervention Condition
Name Route DrugBank ID