Trial · NCT07564726
Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
NCT07564726, Phase 3, Completed, Celltrion Pharm, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol. Trials, record NCT07564726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07564726
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
- NCT number
- NCT07564726
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 163 participants, actual
- Lead sponsor
- Celltrion Pharm, Inc.
- Conditions
- Hypertension, Hypercholesterolemia
- Interventions
- Amlodipine, Ezetimibe/Rosuvastatin, Ezetimibe/Rosuvastatin Placebo, Amlodipine Placebo
- First posted
- 2026-05-04
- Last updated
- 2026-05-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1 | Baseline, Week 8 | Percent change from baseline in LDL-C level. |
| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 in Treatment Group and Control Group 2 | Baseline, Week 8 | Change from baseline in mean sitting systolic blood pressure. Change is calculated as the Week 8 value minus the baseline value. |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4 in the Treatment Group and Control Group 1 | Baseline, Week 4 | Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 4 in the treatment group and control group 1. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 in the Treatment Group and Control Group 2 | Baseline, Week 4 | Change from baseline in mean sitting systolic blood pressure (MSSBP) at Week 4 in the treatment group and control group 2. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Weeks 4 and 8 in the Treatment Group and Control Group 1 | Baseline, Week 4, Week 8 | Change from baseline in mean sitting systolic blood pressure (MSSBP) at Weeks 4 and 8 in the treatment group and control group 1. |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 4 and 8 in the Treatment Group and Control Group 2 | Baseline, Week 4, Week 8 | Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Weeks 4 and 8 in the treatment group and control group 2. |
| Secondary | Percent Change From Baseline in TC, TG, HDL-C, non-HDL-C, and Apo B at Weeks 4 and 8 in the Treatment Group, Control Group 1 and Control Group 2 | Baseline, Week 4, Week 8 | Percent change from baseline in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B (Apo B) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2 | Baseline, Week 4, Week 8 | Change from baseline in mean sitting diastolic blood pressure (MSDBP) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. |
| Secondary | Proportion of Participants Achieving Target Blood Pressure at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2 | Week 4, Week 8 | Proportion of participants who achieved target blood pressure at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. Target blood pressure is defined as MSSBP/MSDBP \<140/90 mmHg. For participants with high-risk diabetes mellitus, chronic kidney disease with diabetes mellitus or albuminuria, concomitant cardiovascular disease, or high-risk hypertension, target blood pressure is defined as MSSBP/MSDBP \<130/80 mmHg. |
| Secondary | Proportion of Participants Achieving Target Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2 | Week 4, Week 8 | Proportion of participants who achieved target low-density lipoprotein cholesterol (LDL-C) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. Target LDL-C is defined according to cardiovascular risk category as follows: very high-risk, \<70 mg/dL; high-risk, \<100 mg/dL; moderate-risk, \<130 mg/dL; and low-risk, \<160 mg/dL. |
Source ClinicalTrials.gov
Outcomes0
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/NCT07564726
GET https://conductscience.org/api/trials/v1/NCT07564726/registered