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IRCT2014041417261N1 IRCT 2014-04-29 Faran Pharmaceutical Company The efficacy study of Farantan on pulmonary arterial hypertension Double blind randomized clinical trial of the Farantan (Bosentan) 125 mg on pulmonary arterial hypertension cases; a product of Faran pharmaceutical Company 2014-05-22 anticipated 30 Complete https://irct.ir/trial/15920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Pulmonary Arterial Hypertension. Intervention 1: Case group: Prescription of Farantan (Bosentan) tablet 125 mg, orally, twice a day, for 2 years. Intervention 2: Control group: prescription of placebo, completely similar to Farantan tablet, orally, 125 mg twice a day for 2 years.
public Dr. Kayvan Saeedfar
Dr M. Daneshvari Hospital, Daar-Abad, Niavaran
Tehrran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2012 K.saeedfar@sbmu.ac.ir National Research Institute of Tuberculosis and Lung Diseases scientific Prof. Mohammad Reza Masjedi
Dr Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2020 mrmasjedi@gmail.com National Research Institute of Tuberculosis and Lung Diseases Iran (Islamic Republic of) 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. no limit no limit Both I27.2 Other secondary pulmonary hypertension Treatment - Drugs Treatment - Drugs Case group: Prescription of Farantan (Bosentan) tablet 125 mg, orally, twice a day, for 2 years Control group: prescription of placebo, completely similar to Farantan tablet, orally, 125 mg twice a day for 2 years 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). 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. Faran Pharmaceutical Company Approved 2013-12-29 National Research Institute of Tuberculosis and Lung Diseases Dr Masih daneshvari Hospital, Daar-Abad, Niavaran Tehran Iran (Islamic Republic of)