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Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

NCT00667823 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2025-03-30

Study results available
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Summary

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Conditions

Interventions

DRUG

Macitentan

Tablet, oral administration, 10 mg dose once daily

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-17
Primary Completion
2020-12-07
Completion
2020-12-07

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • Sweden
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667823 on ClinicalTrials.gov