To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00946114
• Date of registration: 22/07/2009
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
• Scientific title: A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.
• Date of first enrolment: June 2006
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00946114
• Study type: Observational

Countries of recruitment

Poland

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects aged 18 and over who have any of the following conditions:

- Idiopathic pulmonary arterial hypertension.

- PAH associated with connective tissue disease (CTD).

- PAH with surgical repair, at least 5yrs previously, of atrial septal defect
(ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or
aorta-pulmonary window.

2. Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery
wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization.

3. Subjects whose baseline 6-min walk test distance was > 100m and < 450m.

Exclusion Criteria:

1. PAH secondary to any etiology other than those specified in the inclusion criteria.

2. Subjects with congenital heart disease (other than those specified in the inclusion
criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease,
congestive heart failure.

3. Subjects whose 6-Minute Walk test might have been limited by conditions other than
PAH, associated dyspnea or fatigue.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: sildenafil

Primary Outcome(s)

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to 116 Weeks]

Secondary ID(s)

A1481242

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/03/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00946114