NCT07564726 Amlodipine Besylate Primary hypercholesterolemia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07564726 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07564726 is a hot trial to watch
Primary hypercholesterolemia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07564726 is notable because it evaluates Amlodipine Besylate in a Phase 3 design sponsored by Celltrion Pharm Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07564726 |
| Official title | Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol |
| Phase / status | Phase 3 / Completed |
| Intervention | Amlodipine Besylate |
| Sponsor | Celltrion Pharm Inc. |
| Geography | South Korea |
| Enrollment | [object Object] |
| Primary endpoint | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1 |
| Endpoint time frame | Baseline, Week 8 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this clinical trial is to test whether one pill that combines ezetimibe, rosuvastatin, and amlodipine can safely lower cholesterol and blood pressure in Korean adults with high blood pressure and high cholesterol.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across South Korea shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 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.
- 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.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Amlodipine Besylate is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Celltrion Pharm Inc. is resolved to a normalized organization record in South Korea. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07564726 provides a focused lens on Primary hypercholesterolemia development. Its value will be determined by whether Amlodipine Besylate can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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