Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01484431
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2011-11-30
Brief Title:
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension PAH after dosing to establish the correct dose for further clinical research
Detailed Description:
During Period I tadalafil will be administered orally once daily at a low dose for approximately 5 weeks followed by a high dose for approximately 5 weeks Dose levels are calculated based on body weight cohorts Heavy weight cohort 40 kg middle weight cohort 25 kg to 40 kg Light weight cohort25 kg Participants who complete Period 1 may continue taking tadalafil in Period 2 for at least 2 years Starting dose will not exceed the maximum weight range dose established in Period 1 and after the first 3 months of Period 2 the dose may be adjusted based on available safety and efficacy information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H6D-MC-LVIG | OTHER | Eli Lilly and Company | None |