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Trial · NCT02654678

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of patients with Adverse Reactionsup to month 10Adverse Reaction definition according to European Directive 2001/20/EC, assessed at each Visit concerning intensity and causality
SecondaryBlood pressureAt every Visit: (day 0, month 1, 4, 7, 10)Measurement pre-dose after 5 minutes at rest at every Visit up to end of treatment at Month 10
SecondaryReninPre-dose at each Visit: (day 0, month 1, 4, 7, 10)Renin to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
SecondaryAngiotensin 1Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)Angiotensin 1to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
SecondaryAldosteronePre-dose at each Visit: (day 0, month 1, 4, 7, 10)Aldosterone to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
SecondaryPlasma Renin ActivityPre-dose at each Visit: (day 0, month 1, 4, 7, 10)Plasma renin activity to assess the Renin-angiotensin-aldosterone system (RAAS) measured at every Visit up to end of treatment at Month 10
SecondaryCreatininePre-dose at each Visit: (day 0, month 1, 4, 7, 10)Creatinine for renal monitoring measured at every Visit up to end of treatment at Month 10
SecondaryUrea nitrogenPre-dose at each Visit: (day 0, month 1, 4, 7, 10)Urea nitrogen for renal monitoring measured at every Visit up to end of treatment at Month 10
SecondarySerum potassiumPre-dose at each Visit: (day 0, month 1, 4, 7, 10)Serum potassium for renal monitoring measured at every Visit up to end of treatment at Month 10
SecondaryBrain-Natriuretic-Peptides (BNP)Pre-dose at each Visit: (day 0, month 1, 4, 7, 10)BNP measured at every visit up to end of treatment at Month 10 to observe disease severity
SecondaryMicro-albuminuriaPre-dose at each Visit: (day 0, month 1, 4, 7, 10)Measurement of micro-albuminuria for renal monitoring measured at every Visit up to end of treatment at Month 10
SecondaryClinical haematologyDay 0 and Month 10Assessment at First and Last Study Visit at the end of treatment at Month 10
SecondaryECGDay 0 and Month 10Assessment at First and Last Study Visit at the end of treatment at Month 10
SecondaryPlasma concentration of enalapril and its active metabolite enalaprilat under long-term treatmentPre-dose at each Visit: (day 0, month 1, 4, 7, 10)
At each Visit in children under enalapril ODMT treatment a single blood sample will be collected to measure the enalapril and enalaprilat plasma levels during long-term treatment; population-kinetic investigation
SecondaryAcceptability assessment of enalapril ODMTsAt each Visit: (day 0, month 1, 4, 7, 10)Acceptability assessment at each Visit up to end of treatment at 10 months in children under enalapril ODMT treatment according to an age-appropriate scale
SecondaryPalatability assessment of enalapril ODMTsAt each Visit: (day 0, month 1, 4, 7, 10)Palatability assessment at each Visit up to end of treatment at Month 10 in children under enalapril ODMT treatment according to an age-appropriate scale

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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