PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00125918
• Date of registration: 01/08/2005
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
• Scientific 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
• Date of first enrolment: August 2005
• Target sample size: 406
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00125918
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• 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:

- 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

Exclusion Criteria:

- 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.



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

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: tadalafil

Drug: placebo

Primary Outcome(s)

6 minute walk distance change from baseline to Week 16 [Time Frame: 16 weeks]

Secondary Outcome(s)

Time to first occurrence of clinical worsening [Time Frame: Not defined]

World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16 [Time Frame: 16 weeks]

Secondary ID(s)

10303

H6D-MC-LVGY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ICOS Corporation