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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00549302
• Date of registration: 23/10/2007
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs
• Scientific title: An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: December 2005
• Target sample size: 357
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00549302
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Germany, Ireland, Italy, Japan, Spain, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: tadalafil

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)]

Secondary Outcome(s)

Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52 [Time Frame: Baseline and Weeks 16, 28, 40 and 52]

6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52 [Time Frame: Baseline and Weeks 16, 28, 40 and 52]

Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52 [Time Frame: Baseline and Weeks 16, 28, 40 and 52]

Secondary ID(s)

10263

H6D-MC-LVGX

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ICOS Corporation

Results

• Results available: Yes
• Date Posted: 18/02/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00549302