A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
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ClinicalTrials.gov Identifier: NCT01824290 |
Recruitment Status :
Completed
First Posted : April 4, 2013
Results First Posted : March 23, 2020
Last Update Posted : November 5, 2021
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Hypertension, Pulmonary |
Interventions |
Drug: Tadalafil Drug: Placebo Drug: ERA as specific PAH treatment |
Enrollment | 35 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Per protocol and statistical analysis plan (SAP), the primary and secondary analysis from period 1 were performed to compare all tadalafil participants together versus all placebo participants together. |
Arm/Group Title | Placebo | Tadalafil | Placebo/Tadalafil | Tadalafil/Tadalafil |
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Period 1: Participants received placebo orally by tablets once a day. | Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day. |
Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day. Participants had received placebo during period 1. |
Period 2: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered tadalafil orally by tablets once a day. Participants had received tadalafil during period 1. |
Period Title: Period 1: Double Blind | ||||
Started | 18 | 17 | 0 | 0 |
Received at Least One Dose of Study Drug | 18 | 17 | 0 | 0 |
Received 20 mg | 0 | 4 | 0 | 0 |
Received 40 mg | 0 | 13 | 0 | 0 |
Completed | 15 | 15 | 0 | 0 |
Not Completed | 3 | 2 | 0 | 0 |
Reason Not Completed | ||||
Entry Criteria Not Met | 1 | 0 | 0 | 0 |
Parent/Caregiver Decision | 1 | 1 | 0 | 0 |
Investigator Reported Clinical Worsening | 1 | 1 | 0 | 0 |
Period Title: Period 2: Open-Label Treatment | ||||
Started | 0 | 0 | 16 [1] | 16 [1] |
Received 20 mg | 0 | 0 | 3 | 3 |
Received 40 mg | 0 | 0 | 13 | 13 |
Completed | 0 | 0 | 13 | 13 |
Not Completed | 0 | 0 | 3 | 3 |
Reason Not Completed | ||||
Adverse Event | 0 | 0 | 0 | 1 |
Parent/caregiver Decision | 0 | 0 | 1 | 1 |
Withdrawal by Subject | 0 | 0 | 2 | 1 |
[1]
As per the protocol, period 2 eligibility were participants who completed period 1 or experienced clinical worsening (CW) in period 1. 1 participant that had CW in period 1 continued to period 2.
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Baseline Characteristics
Arm/Group Title | Placebo | Tadalafil | Total | |
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Period 1: Participants received placebo orally by tablets once a day. | Period 1: 20 mg middle weight cohort or 40 mg for heavy weight cohort administered orally by tablets once a day. | Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 17 | 35 | |
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All participants who received at least one dose of study drug. Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all tadalafil participants together versus all placebo participants together.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
12.8 (3.39) | 14.1 (3.49) | 13.5 (3.45) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
Female | 9 | 10 | 19 | |
Male | 9 | 7 | 16 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
Hispanic or Latino | 7 | 8 | 15 | |
Not Hispanic or Latino | 6 | 4 | 10 | |
Unknown or Not Reported | 5 | 5 | 10 | |
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
American Indian or Alaska Native | 1 | 3 | 4 | |
Asian | 1 | 1 | 2 | |
Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | |
Black or African American | 2 | 1 | 3 | |
White | 14 | 12 | 26 | |
More than one race | 0 | 0 | 0 | |
Unknown or Not Reported | 0 | 0 | 0 | |
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 18 participants | 17 participants | 35 participants |
Japan | 1 | 1 | 2 | |
Turkey | 2 | 1 | 3 | |
Brazil | 9 | 6 | 15 | |
Mexico | 1 | 4 | 5 | |
Israel | 2 | 4 | 6 | |
France | 1 | 1 | 2 | |
Germany | 1 | 0 | 1 | |
Poland | 1 | 0 | 1 | |
6 Minute Walk Distance
Mean (Standard Deviation) Unit of measure: Meters |
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Number Analyzed | 18 participants | 17 participants | 35 participants | |
476.7 (105.11) | 485.8 (160.231) | 481.1 (132.77) |
Outcome Measures
Adverse Events
Limitations and Caveats
The study is mainly descriptive in a small number of children with PAH and there were no participants enrolled in the light weight cohort.
More Information
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | Eli Lilly and Company |
Phone: | 800-545-5979 |
EMail: | ClinicalTrials.gov@lilly.com |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01824290 |
Other Study ID Numbers: |
10609 H6D-MC-LVHV ( Other Identifier: Eli Lilly and Company ) 2012-002354-23 ( EudraCT Number ) |
First Submitted: | April 1, 2013 |
First Posted: | April 4, 2013 |
Results First Submitted: | March 6, 2020 |
Results First Posted: | March 23, 2020 |
Last Update Posted: | November 5, 2021 |