|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eli Lilly and Company |
|---|---|
| Collaborator: |
ICOS Corporation |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00125918 |
Purpose
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: tadalafil Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension |
| Enrollment: | 406 |
| Study Start Date: | August 2005 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Placebo
|
Drug: placebo
placebo tablet taken by mouth once a day for 16 weeks
|
|
2: Active Comparator
2.5 mg tadalafil
|
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
|
|
3: Active Comparator
10 mg tadalafil
|
Drug: tadalafil
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
|
|
4: Active Comparator
20 mg tadalafil
|
Drug: tadalafil
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
|
|
5: Active Comparator
40 mg tadalafil
|
Drug: tadalafil
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
|
This is a randomized, double-blind, placebo-controlled, multicenter study. The key measure of effectiveness of the study drug will be determined using a 6-minute walk test. Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study (PHIRST-2). Study procedures for both studies (PHIRST-1 and PHIRST-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| 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. | |
| Tucson, Arizona, United States, 85724 | |
| United States, Minnesota | |
| 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. | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Utah | |
| 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. | |
| Salt Lake City, Utah, United States, 84143 | |
| 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, 59037 | |
| 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. | |
| Vandoeuvre Les Nancy, France, 54511 | |
| 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, 24128 | |
| 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
| Study ID Numbers: | 10303, H6D-MC-LVGY |
| Study First Received: | August 1, 2005 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00125918 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypertension, Pulmonary; Pulmonary Heart Disease |
|
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Tadalafil |
Vascular Diseases Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Hypertension |