Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ERA as specific PAH treatment · 1 trial · 1 indication
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...
ERA as specific PAH treatment is a small molecule being developed by Eli Lilly and Company for pulmonary hypertension, specifically pulmonary arterial hypertension (PAH). It is an investigational therapy studied in a Phase 3 clinical trial in pediatric participants with PAH.
ERA as specific PAH treatment is an endothelin receptor antagonist (ERA). It works by blocking endothelin receptors, which are involved in the narrowing of blood vessels in pulmonary arterial hypertension. This mechanism helps address the underlying pathophysiology of PAH.
ERA as specific PAH treatment is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational therapy for pulmonary arterial hypertension.
ERA as specific PAH treatment is in Phase 3 clinical development. It has completed a Phase 3 trial in pediatric participants with pulmonary arterial hypertension. The drug is investigational and has not been approved by regulatory authorities based on the available information.
ERA as specific PAH treatment was studied in a Phase 3 clinical trial with the identifier NCT01824290, titled 'A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)'. This randomized, double-blind, placebo-controlled trial enrolled 35 participants and has been completed.
ERA as specific PAH treatment is not the same as tadalafil. The clinical trial NCT01824290 studied tadalafil in pediatric participants with pulmonary arterial hypertension. ERA refers to the class of endothelin receptor antagonists, while tadalafil is a different medication, a phosphodiesterase-5 inhibitor.