Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

Viatris

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: sildenafil citrate

Study type: Observational

Funder types: Industry

Identifiers

NCT01365585

A1481297

Details and patient eligibility

About

The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

Full description

The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be at least 18 years of age at study index;
• Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
• Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation

Exclusion criteria

• Patient has known contraindications to sildenafil at study index;
• Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index

Trial design

227 participants in 1 patient group

Sildenafil ≥20mg three times daily

Description:

Subjects receiving sildenafil ≥20mg three times daily for the treatment of PAH

Treatment:

Drug: sildenafil citrate