✓ Translated by DotMD AI Clinical Council Source: Clinical therapeutics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40122716 ↗

Phase III Randomized Trial: A Phase III Randomized, Double-Blind, Active-Controlled, Multicenter Study on the Efficacy and Safety of Ezetimibe/Atorvastatin/Amlodipine Combination in Patients With Comorbid Primary Hypercholesterolemia and Essential Hypertension (N = 109)

Original Paper Title: “A Phase III Randomized, Double-Blind, Active-Controlled, Multicenter Study on the Efficacy and Safety of Ezetimibe/Atorvastatin/Amlodipine Combination in Patients With Comorbid Primary Hypercholesterolemia and Essential Hypertension”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 109
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups.
  • Study Design & Sample: Phase III Randomized Trial published in Clinical therapeutics (N = 109 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical therapeutics (2025), this phase iii randomized trial evaluating 109 human participants investigated: This study aimed to evaluate the efficacy and safety of triple combination of ezetimibe (Eze)/atorvastatin (Ato) 10/40 mg + amlodipine (Aml) 10 mg therapy for lowering the low-density lipoprotein cholesterol (LDL-C) and blood pressure compared with either Eze/Ato 10/40 mg or Aml 10 mg therapies in patients with comorbid primary hypercholesterolemia and essential hypertension. Key clinical takeaway: A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Clinical therapeutics, 2025-06-15; N = 109; Rigor 88/100): A total of 109 participants were enrolled in the study, and there were no statistically significant differences in the baseline characteristics of participants across the 3 groups.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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