Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00549302
Eligibility Criteria:
Inclusion Criteria:
* Must have participated and discontinued in the previous PAH placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
* Must have completed Week 16 of the previous PAH study and had either no clinical worsening or became clinically worse at the Week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
* Females who have a negative urine pregnancy test and are willing to use 2 types of birth control
* Be 12 years or older (country specific regulations apply) with parental approval
Exclusion Criteria:
* Participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
* Have left-sided heart disease
* Have a musculoskeletal disorder that limits being able to get around
* Nitrate use
* Certain current systemic treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00549302
Study Brief:
Protocol Section:
NCT00549302