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 : September 13, 2018
|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|
|Actual Study Start Date :||February 5, 2014|
|Estimated Primary Completion Date :||January 13, 2021|
|Estimated Study Completion Date :||January 16, 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
Show 46 Study Locations
|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|