NCT01683981|UnknownEarly Phase 1DMC
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Sponsor study identifier
interventional
25
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Due to vasodilatory properties of the NO, one of the therapeutic approaches for IPAH is oral use of nitric oxide precursors (10). Efficacy of L-arginine is well-documented in the current literature but there is paucity of data with regard to L-citrulline- malate. Hence, this study will evaluate therapeutic efficacy of L-citrulline- malate in two categories of patients with pulmonary hypertension (IPAH, and Eisenmeger syndrome). This randomized clinical trial utilizes 6-minute walk, pro BNP levels and the echocardiographic indexes an indicator of functional improvement of the patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 1, 2012
Actual (reported)September 12, 2012
Actual (reported)August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
the change in exercise capacity
The primary measure of efficacy was the change in exercise capacity, as measured by the total distance walked in six minutes, from baseline to week 2. (15)
2 weeks
changes in mean pulmonary-artery pressure
2 weeks
change in the quality of life
2 weeks
L-Citrulline malate, 1gr, oral, divided 3 times a day,for 2 weeks
3 gr per day, oral, for 2 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MasihDH
Tehran, 021, Iran
babak sharif kashani, cardiologist
Lung Transplantation Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Science, Tehran, Iran.
Paritash Tahmaseb pour, MD
MD
First Submitted
September 1, 2012
First Posted
September 12, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 12, 2013
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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