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L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03402191
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 18, 2018
Last Update Posted Date August 27, 2018
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Number of patients with improvement of pulmonary hypertension [ Time Frame: 6 months ]
patients with improvement of pulmonary hypertension
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Official Title  ICMJE Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Brief Summary This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia
Detailed Description This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia
Intervention  ICMJE
  • Drug: L-arginine
    l-arginine for thalassemia with pulmonary hypertension
  • Drug: Sildenafil
    Sildenafil for thalassemia with pulmonary hypertension
    Other Name: Viagra
Study Arms  ICMJE
  • Active Comparator: L-arginine
    l-arginine for pulmonary hypertension in patients with thalassemia.
    Intervention: Drug: L-arginine
  • Active Comparator: Sildenafil
    Sildenafil for pulmonary hypertension in patients with thalassemia.
    Intervention: Drug: Sildenafil
  • No Intervention: Control
    No pulmonary hypertension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

  • Rheumatic heart diseases.
  • Other comorbid disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, MD 00201095159522 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03402191
Other Study ID Numbers  ICMJE Prof Elshanshoury
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sahar El-Haggar, Prof Tanta University - Faculty of Pharmacy
Study Director: Mohamed El-Shanshoury, Prof Tanta University Pediatrics Department
Study Chair: Osama Abd-rab El-Rasol, Prof Tanta University Pediatrics Department
Study Chair: Tarek Mostafa, Ass Prof Tanta University-Faculty of pharmacy
Study Chair: Eman El-Khateeb, Msc Tanta University-Faculty of pharmacy
PRS Account Tanta University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP