The efficacy study of Farantan on pulmonary arterial hypertensio

Not Applicable

• Conditions: Pulmonary Arterial Hypertension.; Other secondary pulmonary hypertension

• Registration Number: IRCT2014041417261N1
• Lead Sponsor: Faran Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion:
•The cases of pulmonary arterial hypertension (PAH), secondary to cardiac or connective tissue disorders (e.g. scleroderma, Eisenmenger's syndrome, etc.), which are in functional class II or higher (Due to drug deficiency and national guideline, Traclleer has not been prescribed for these patients, so far);
•No finding of anemia, liver disorders, pregnancy and lactation, body fluid retention, peripheral or pulmonary edema and respiratory system infections;
•No prescription of interactive medicines like Cyclosporine A and Glyburide;
•Having voluntarily willingness for participation in the study;
Exclusion:
•Drug intolerance due to any reason;
•Any severe or relatively severe side effects like increasing liver function tests (more than 3 times of baseline or 2 times of normal), anemia, severe pulmonary infection, fluid retention and edema, etc.;
•Discontinuing of participation by the participants;
•Irregular intake of Farantan due to any reason;
•Any undesirable medical condition which urge the physicians to change the treatment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6 Minutes Walking Test (6MWT). Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Distanse of walking in 6 minutes (in standard conditions).

Secondary Outcome Measures

Name	Time	Method
ProBNP. Timepoint: at the begining and then every 3 months. Method of measurement: Enzyme-Linked Fluorescent Assay.;CBC. Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Autoanalyzer equipments.;Liver function test. Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Autoanalyzer equipments.