N/A N=32

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

Pulmonary Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00946114 ↗

Enrolled (actual)

Serious AEs

31.3%

Results posted

Mar 2010

Primary outcome: Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 11; 8; 8; 2 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: sildenafil (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)	11; 8; 8; 2	—

Summary

The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.

Eligibility Criteria

Inclusion Criteria

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.
Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) 100m and < 450m.

Exclusion Criteria

PAH secondary to any etiology other than those specified in the inclusion criteria.
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.
Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00946114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.