A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISIO

Phase 1

• Conditions: primary pulmonary hypertension ICD IX 416.8; MedDRA version: 9.1Level: LLTClassification code 10037400Term: Pulmonary hypertension

• Registration Number: EUCTR2005-006192-13-IT
• Lead Sponsor: COTHERIX, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-12
• Study Completion: 2008-07-01
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Inclusion criteria Age 18-80 years, of either gender PAH due to IPAH, FPAH, connective tissue disease, HIV infection, repaired 8805; 1 year ASD, VSD, or PDA, or druginduced e.g. anorexigens Previous documentation of PAH by right heart catheterization within the prior 3 years demonstrating mPAP 25mmHg at rest, PCWP 8804;15mmHg and PVR 8805; 240 dynes sec cm-5 6-MWD between 100-425 meters at screening On a stable dose of sildenafil for at least 12 weeks prior to screening at a dose between 20 and 80 mg TID
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria Any treatment for PAH with prostacyclins, prostacyclin analogues, PDE-5 inhibitors other than sildenafil, or endothelin-1 antagonists within the past 12 weeks. Pulmonary hypertension due to conditions other than as stated in inclusion criteria. Additional PAH medications added within the past 12 weeks

Study & Design

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