Trial · NCT02654678
Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril
NCT02654678, Phase 2, Phase 3, Unknown, Ethicare GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril. Trials, record NCT02654678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril
- NCT number
- NCT02654678
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Ethicare GmbH
- Conditions
- Heart Failure, Dilated Cardiomyopathy, Congenital Heart Disease
- Interventions
- Enalapril Orodispersible Minitablet
- First posted
- 2016-01-13
- Last updated
- 2016-01-13
- Other registries' IDs
- eudract:2015-002397-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with Adverse Reactions | up to month 10 | Adverse Reaction definition according to European Directive 2001/20/EC, assessed at each Visit concerning intensity and causality |
| Secondary | Blood pressure | At 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 |
| Secondary | Renin | Pre-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 |
| Secondary | Angiotensin 1 | Pre-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 |
| Secondary | Aldosterone | Pre-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 |
| Secondary | Plasma Renin Activity | Pre-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 |
| Secondary | Creatinine | Pre-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 |
| Secondary | Urea nitrogen | Pre-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 |
| Secondary | Serum potassium | Pre-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 |
| Secondary | Brain-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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02654678
GET https://conductscience.org/api/trials/v1/NCT02654678/registered