A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
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|ClinicalTrials.gov Identifier: NCT01824290|
Recruitment Status : Recruiting
First Posted : April 4, 2013
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary||Drug: Tadalafil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2023|
Period 1 (6-month double-blind): Final tadalafil doses will be assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431). Tadalafil doses may 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.
Period 2 (2-year open-label extension): Participants receiving tadalafil in Period 1 will continue at same dose in Period 2.
Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.
Placebo Comparator: Placebo
Period 1 (6-month double-blind): Final placebo dose will be assigned after the weight cohort completion from H6D-MC-LVIG (NCT01484431) to maintain blinding depending on body weight cohort.
Period 2 (2-year open-label extension): Participants receiving placebo in Period 1 will receive tadalafil in Period 2 at the corresponding tadalafil dose in that participant's weight group.
Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
- Period 1: Change from Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters [ Time Frame: Baseline, Week 24 ]
- Period 1: Time to First Occurence of Clinical Worsening (CW) [ Time Frame: Baseline through Week 24 ]
- Period 2: Time to First Occurence of CW [ Time Frame: Baseline through Study Completion (Estimated up to 24 Months) ]
- Period 2: Percentage of Participants Who Experience CW [ Time Frame: Baseline through Study Completion (Estimated up to 24 Months) ]
- Period 1: Percentage of Participants Who Experience CW [ Time Frame: Baseline through Week 24 ]
- Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of tadalafil [ Time Frame: Week 2, 4, 16 and 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824290
|Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)||1-317-615-4559|
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|Study Director:||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|