A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A

Phase 1

• Conditions: Pulmonary Arterial Hypertension; MedDRA version: 8.1Level: LLTClassification code 10064911

• Registration Number: EUCTR2005-000963-25-SK
• Lead Sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-20
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

· Pediatric subjects, who enrolled in and completed Study A1481131;
· Females of childbearing potential who are sexually active must be practicing a suitable method of birth control so that in the opinion of the investigator, they will not become pregnant during the study; and
· The investigator must obtain written informed consent and assent where applicable before the subject is considered for enrollment in Study A1481156. The inclusion of a subject more than once in the same clinical trial is not permissible.
All inclusion criteria must be adhered to.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pediatric subjects, who did not complete Study A1481131.
• Subjects with known hereditary degenerative retinal disorders (such as retinitis
pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION).

The exclusion criteria must be adhered to.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified