Official 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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 20 mg tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.
• Drug: tadalafil
  • 40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 20 mg tadalafil taken once a day
• Active Comparator: 2
  • 40 mg tadalafil tablet taken once a day

Primary Measures

• Incidence of reported Adverse Events along with changes in laboratory values and vital signs outside of set ranges.
  • Time Frame: For the duration of the study
    Safety Issue?: Yes

Secondary Measures

• Changes in the Six minute walk test with Borg Score
  • Time Frame: 52 weeks
    Safety Issue?: No
• Time to deterioration using the WHO functional classification assessment
  • Time Frame: 52 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00549302

Study ID Number: 10263

ClinicalTrials.gov Identifier: NCT00549302

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry