Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
20 mg tadalafil	tadalafil	20 milligram (mg) tadalafil taken once a day
40 mg tadalafil	tadalafil	40 mg tadalafil tablet taken once a day

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)	A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.

Secondary Outcome Measures

Name	Time	Method
6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52	Baseline and Weeks 16, 28, 40 and 52	6MWD measured the distance a participant was able to walk unassisted in 6 minutes.
Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52	Baseline and Weeks 16, 28, 40 and 52	Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe \[maximal\]).
Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52	Baseline and Weeks 16, 28, 40 and 52	World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧
London, United Kingdom