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A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

NCT01824290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-11-05

Study results available
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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.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Tadalafil

Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.

DRUG

Placebo

Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.

DRUG

ERA as specific PAH treatment

All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-05
Primary Completion
2019-03-18
Completion
2021-03-10

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824290 on ClinicalTrials.gov