Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01824290 | A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) | PHASE3 | COMPLETED | 35 | — | — | Feb 5, 2014 | Mar 10, 2021 | Nov 5, 2021 | 43 | United States, Austria +12 |
6MWD in meters assessed in a subset of participants who are ≥6 to \<18 years of age who are developmentally capable of performing a 6MW test. Change from baseline was derived using mixed model repeated measures (MMRM) with terms for treatment group, visit, baseline 6MWD, and treatment-by-visit interaction.
| Arm | Type | Description |
|---|---|---|
| Tadalafil | EXPERIMENTAL | Period 1: 20 mg or 40 mg administered orally by tablets once a day. Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day. Final tadalafil doses for Period 1 (6-month double-blind) were assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431).Tadalafil doses would range from 5 milligram (mg) to 40 mg depending on body weight cohorts. Heavy weight cohort ≥40 kilogram (kg), Middle weight cohort ≥25 kg to \<40 kg: administered orally by tablets once a day. Light weight cohort \<25 kg: administered orally by suspension once a day. Participants receiving tadalafil in Period 1 continued to receive tadalafil during Period 2 (2-year open-label extension). |
| Placebo | PLACEBO_COMPARATOR | Period 1: Participants received placebo orally by tablets once a day. Period 2: 20 mg for middle weight and 40 mg for heavy weight administered orally by tablets once a day. Final placebo dose for Period 1 (6-month double-blind) was be assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431) to maintain blinding depending on body weight cohort. Participants receiving placebo in Period 1 Period 2 (2-year open-label extension) would receive tadalafil in Period 2 at the corresponding tadalafil dose in that participant's weight group. |
| Name | Type | Description |
|---|---|---|
| Tadalafil | DRUG | Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants. |
| Placebo | DRUG | Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants. |
| ERA as specific PAH treatment | DRUG | All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan). |
Inclusion Criteria: * ≥6 months to \<18 years of age at screening * Currently have a diagnosis of PAH that is either: * idiopathic, including hereditary * related to connective tissue disease * related to anorexigen use * associated with surgical repair of at least 6-month duration of cong...