Trial · NCT03555123
Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX
NCT03555123, Phase 3, Unknown, Yooyoung Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX. Trials, record NCT03555123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03555123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX
- NCT number
- NCT03555123
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 112 participants, estimated
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Simdax
- First posted
- 2018-06-13
- Last updated
- 2021-05-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of the Clinical Composite Classification(CCC) | 5day | Assessment of the Clinical Composite Classification(CCC) using the Patients Global Assessment(PGA) at 5day after start of IV levosiemendan or Placebo infusion with WHF through 5dyas: Improved, Unchanged, Worse |
| Secondary | BNP | baseline to 24hr, 48hr, 72hr, and 5day | Change from baseline in plasma BNP levels at 24hr, 48hr, 72hr, and 5day |
| Secondary | ST2 | baseline to 24hr, 48hr, 72hr, and 5day | Change from baseline in plasma ST2 at 24hr, 48hr, 72hr, 5day |
| Secondary | NYHA | baseline to 5day | New York Heart Association(NYHA) functional classification at 5 days. |
| Secondary | hospitalization | 31day | Length of intensive care unit and /or Coronary care unit stay for the index ADHF hospitalization |
| Secondary | cardio-renal biomarkers | baseline to 24hr, 48hr, 72hr, and 5day | Change from baseline in cardio-renal biomarkers (Creatinine, BUN, NGAL) at 24hr, 48hr, 72hr and 5day |
| Secondary | Patient's Global Assessment | 6hr | Patient's Global Assessment (PGA, 7-likert scale) at 6 hr. : Check rate of patients who responded with Moderate or Marked improvement |
| Secondary | Patients Assessment | 6hr | Patients Assessment of dyspnea(7-likert scale) at 6hr : Check rate of patients who responded with Moderate or Marked improvement |
| Secondary | re-hospitalization | 30days | Time to re-hospitalization due to heart failure after discharge |
| Secondary | death. | 30days | Time to CV death. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT03555123
GET https://conductscience.org/api/trials/v1/NCT03555123/registered