Safety and Efficacy of Continued CS1 Treatment of Patients With Pulmonary Arterial Hypertension

NCT06321705 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-03-20

No results posted yet for this study

Summary

CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1.

Conditions

Interventions

DRUG

CS1

CS1 delayed release capsules will be supplied with 160 mg active pharmaceutical ingredient (API) per capsule. Three dose levels will be administered in this expanded access study at the same dose the patient received in the parent study (CS1-003) of 480 mg, 960 mg, or 1920 mg. All patients will later have the option to be titrated to the most efficacious and safe dose determined from the ongoing CS1-003 study when completed.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER
  • Abbott

    collaborator INDUSTRY
  • Cereno Scientific AB

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Sweden

Study Locations

More Related Trials

Entities

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 NCT06321705 on ClinicalTrials.gov