PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Hypertension
In brief
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
Key facts
- Study ID
- NCT00125918
- Run by
- Eli Lilly and Company
- People needed
- 406
- Starts
- 2005-08-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2008-02-21
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 12 years of age.
- Body weight at least 40 kg (approximately 88 pounds).
- Pulmonary hypertension (PAH) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 greater than or equal to 88%); with surgical repair, of at least 1 year duration, of a congenital systemic-to-pulmonary shunt.
- If on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an AST/ALT less than 3 times normal.
- History of PAH established by a resting mean pulmonary artery pressure greater than or equal to 25 mm Hg, pulmonary artery wedge pressure less than or equal to 15 mm Hg, and pulmonary vascular resistance greater than or equal to 3 Wood units via right heart catheterization
- Have World Health Organization functional class I, II, III or IV status.
- Have a qualifying 6-minute walk test distance at screening
- Have no evidence of significant parenchymal lung disease
You may not qualify if…
- Are nursing or pregnant.
- PAH due to conditions other than noted in the above inclusion criteria.
- History of left-sided heart disease.
- History of atrial septostomy within 3 months before study entry
- History of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
- History of symptomatic coronary disease.
- Have any therapy with a prostacyclin or analogue, L-arginine, phosphodiesterase (PDE) inhibitor, or investigational drug within 4 weeks before administration of study drug.
Where it is running
- 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
- 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
- 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
- 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
- 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. — Vandœuvre-lès-Nancy, 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. — Bergamo, Italy
Full record on ClinicalTrials.gov
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