Double blind randomized clinical trial of the Farantan (Bosentan) 125 mg on pulmonary arterial hypertension cases; a product of Faran pharmaceutical Company
Aim: The evaluation study of Farantan (Iranian made Bosentan) in treatment of pulmonary arterial hypertension
Study: Double blind randomized clinical trial with placebo in control group
Inclusion criteria:Secondary cases of pulmonary arterial hypertension in functional class of II or higher
Exclusion criteria: intolerance or any severe or relatively severe side effects
Study population: Referring cases of pulmonary arterial hypertension to its clinic
Sample size:two group, each one 15 participants
Intervention: Prescribing Farantan (Iranian made Bosentan), 125 mg twice a day for 2 years
Main outcome: 6 minutes walking test
Secondary outcomes: clinical evaluations, ProBNP, blood and liver tests
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041417261N1
Registration date:2014-04-29, 1393/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-29, 1393/02/09
Registrant information
Name
Kayvan Saeedfar
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseseas
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2012
Email address
k.saeedfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faran pharmaceutical company
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized clinical trial of the Farantan (Bosentan) 125 mg on pulmonary arterial hypertension cases; a product of Faran pharmaceutical Company
Public title
The efficacy study of Farantan on pulmonary arterial hypertension
Purpose
Treatment
Inclusion/Exclusion 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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Institute of Tuberculosis and Lung Diseases
Street address
Dr Masih daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Postal code
1956944413
Approval date
2013-12-29, 1392/10/08
Ethics committee reference number
Sbmu1.REC.1392.42
Health conditions studied
1
Description of health condition studied
Pulmonary Arterial Hypertension
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
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 outcomes
1
Description
ProBNP
Timepoint
at the begining and then every 3 months
Method of measurement
Enzyme-Linked Fluorescent Assay
2
Description
CBC
Timepoint
monthly up to 6 month & then every 3 months
Method of measurement
Autoanalyzer equipments
3
Description
Liver function test
Timepoint
monthly up to 6 month & then every 3 months
Method of measurement
Autoanalyzer equipments
Intervention groups
1
Description
Case group:
Prescription of Farantan (Bosentan) tablet 125 mg, orally, twice a day, for 2 years
Category
Treatment - Drugs
2
Description
Control group: prescription of placebo, completely similar to Farantan tablet, orally, 125 mg twice a day for 2 years
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Elmira Ghashghaei Davari
Street address
Dr M. Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehrran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faran Pharmaceutical Company
Full name of responsible person
Ghasemali Ashofteh
Street address
2nd floor, No 19, Parvin Street, Valiasr Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faran Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Kayvan Saeedfar
Position
Executive manager
Other areas of specialty/work
Street address
Dr M. Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehrran
Postal code
19569-44413
Phone
+98 21 2712 2012
Fax
+98 21 2610 9930
Email
K.saeedfar@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Prof. Mohammad Reza Masjedi
Position
Prof. of Pulmonology
Other areas of specialty/work
Street address
Dr Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Postal code
1956944413
Phone
+98 21 2712 2020
Fax
+98 21 2610 9848
Email
mrmasjedi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Kayvan Saeedfar
Position
Executive manager
Other areas of specialty/work
Street address
Dr Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2012
Fax
+98 21 2610 9930
Email
k.saeedfar@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)