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Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00159887
Enrollment
260
Registered
2005-09-12
Start date
2002-12-31
Completion date
2007-02-28
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Brief summary

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

Interventions

DRUGSildenafil citrate

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with PAH who had completed the 12 week pivotal study

Exclusion criteria

* Any other patients with PAH that had not been included into the pivotal study

Design outcomes

Primary

MeasureTime frame
Safety—
Standard safety data—
Efficacy—
6-Minute Walk Test—
BORG Dyspnoea Score—
WHO Functional Class—
Quality of Life SF-36 and EQ-5D—

Countries

Australia, Belgium, Brazil, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Singapore, South Africa, South Korea, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026