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

Sponsors and Collaborators:	Eli Lilly and Company ICOS Corporation
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00549302

Purpose

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.

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: tadalafil	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Tadalafil

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in the Six minute walk test with Borg Score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Time to deterioration using the WHO functional classification assessment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2005
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 20 mg tadalafil taken once a day	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.
2: Active Comparator 40 mg tadalafil tablet taken once a day	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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549302

Locations

United States, Oregon
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.
Bend, Oregon, United States, 97701
Belgium
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.
Brussels, Belgium
Canada, Ontario
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.
Toronto, Ontario, Canada
France
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.
Lille, France
Germany
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.
Berlin, Germany
Ireland
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.
Dublin, Ireland
Italy
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.
Bergamo, Italy
Japan
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.
Tokyo, Japan
Spain
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.
Barcelona, Spain
United Kingdom
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

Sponsors and Collaborators

Eli Lilly and Company

ICOS Corporation

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly and Company ( Chief Medical Officer )
Study ID Numbers:	10263, H6D-MC-LVGX
Study First Received:	October 23, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00549302 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Tadalafil
Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Tadalafil

Vascular Diseases
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009