Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000359033
Ethics application status
Approved
Date submitted
28/04/2010
Date registered
6/05/2010
Date last updated
6/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial of Angipars in patients with pulmonary hypertension.
Scientific title
Phase II clinical trial of oral form Angipars on quality of life and pulmonary artery pressure in patients with primary pulmonary hypertension without control group.
Secondary ID [1] 251679 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 257261 0
Condition category
Condition code
Respiratory 257401 257401 0 0
Other respiratory disorders / diseases
Cardiovascular 257402 257402 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adminstration of oral form of Angipars(Semeli)containing 100 mg active ingredient, three times a day for six months.
Intervention code [1] 256381 0
Treatment: Drugs
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258326 0
6 minute walking distance. This is the distance that patintt can walk in 6 minutes and is thr primary outcome itself.
Timepoint [1] 258326 0
At the Start of treatment, 3rd, 6th and 9th month.
Primary outcome [2] 258327 0
Pulmonary artery pressure measured by echocardiography.
Timepoint [2] 258327 0
At the Start of treatment, 3rd, 6th and 9th month.
Secondary outcome [1] 264033 0
World Health Organization (WHO) Functional class.
Timepoint [1] 264033 0
Baseline then Monthly for 9 months.
Secondary outcome [2] 264034 0
Dyspnea(Borg) quality of life
Timepoint [2] 264034 0
Baseline then Monthly for 9 months.

Eligibility
Key inclusion criteria
Primary pulmonary hypertension.
Stable functional class II more than 4 months.
Six Minuth Walking Distance(6MWD) between 150-425 meters.
Forced Expiratory Volume during one second(FEV1)>40% and pulmonary artery pressure more than 25 mmHg at rest or 30 during activity.
FEV1<25% that do not respond to full dose anti infammatory or bronchodilators.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiopulmonary condition in last three months.
6MWD less than 150 meters.
Diastolic blood pressure less than 85 mmHg.
Bosentan or Prostanoid intake during 3 months before Entering study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 2605 0
Iran, Islamic Republic Of
State/province [1] 2605 0
Tehran

Funding & Sponsors
Funding source category [1] 256884 0
Self funded/Unfunded
Name [1] 256884 0
Dr. Haleh Hamedifar
Country [1] 256884 0
Iran, Islamic Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Pars Roos Biotechnology Co.
Address
No.568, 13th Alley, Hormozan st., Shahrak gharb, Tehran,14678, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256157 0
Hospital
Name [1] 256157 0
Shariaty Hospital
Address [1] 256157 0
Shariaty Hospital, North Kargar st., Tehran,14114, Iran
Country [1] 256157 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258895 0
Digestive Disease Research Center Ethic Committee
Ethics committee address [1] 258895 0
Ethics committee country [1] 258895 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 258895 0
18/01/2010
Approval date [1] 258895 0
17/03/2010
Ethics approval number [1] 258895 0
416/102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31105 0
Address 31105 0
Country 31105 0
Phone 31105 0
Fax 31105 0
Email 31105 0
Contact person for public queries
Name 14352 0
Dr. Omolbanin Paknejad
Address 14352 0
Shariaty Hospital, North kargar st., Tehran, 14114, Iran
Country 14352 0
Iran, Islamic Republic Of
Phone 14352 0
00982184901
Fax 14352 0
00982188633039
Email 14352 0
[email protected]
Contact person for scientific queries
Name 5280 0
Dr. Omolbanin Paknejad
Address 5280 0
Shariaty Hospital, North kargar st., Tehran, 14114, Iran
Country 5280 0
Iran, Islamic Republic Of
Phone 5280 0
00982184901
Fax 5280 0
00982188633039
Email 5280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.