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Phosphodiesterase Type 5 (PDE5) Inhibitor

Tadalafil for Congenital Heart Defects

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up period 2 baseline through study completion (up to 24 months)

Awards & highlights

Pivotal Trial

Summary

The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.

Eligible Conditions

Congenital Heart Defects
Pulmonary Hypertension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ period 2 baseline through study completion (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~period 2 baseline through study completion (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and period 2 baseline through study completion (up to 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Period 1: Change From Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters

Secondary study objectives

Period 1: Percentage of Participants Who Experience CW

Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at Steady-state

Period 1: Time to Adjudicated Clinical Worsening (CW)

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TadalafilExperimental Treatment2 Interventions

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).

Group II: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tadalafil

2014

Completed Phase 4

~3280

ERA as specific PAH treatment

2014

Completed Phase 3

~40