Phase 3
N=357
Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
Hypertension, Pulmonary
Bottom Line
View on ClinicalTrials.gov: NCT00549302 ↗Enrolled (actual)
357
Serious AEs
51.5%
Results posted
Feb 2013
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 184; 334 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tadalafil (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
184; 334 | — |
| SECONDARY 6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 |
397.74; 375.38; 396.37; 381.47; 406.41; 384.97 | — |
| SECONDARY Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 |
3.41; 3.65; 3.41; 3.51; 3.46; 3.44 | — |
| SECONDARY Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 |
95; 96; 88; 90; 81; 88 | — |
Summary
Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.
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
Data sourced from ClinicalTrials.gov (NCT00549302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.