Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets

NCT03847506 | Completed Phase 4

• 1 other identifier: CJ_RVZ_401
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and the safety of concomitant use of Ezetimibe/Rosuvastatin combination tablets and Candesartan cilexetil/Amlodipine besylate combination tablets compared to each combination tablet alone in patients with essential hypertension (HTN) and hyperlipidemia.

Conditions

Hypertension, Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Change in sitting Systolic Blood Pressure(siSBP) from baseline after 6 weeks of study treatment

  EZE/ROS + CAN/AML arm vs. EZE/ROS + CAN arm Change in siSBP from baseline after 6 weeks of study treatment For the siSBP at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean change in baseline-adjusted siSBP from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the analysis of covariance (ANCOVA) with change in siSBP as response variable and baseline siSBP and treatment arm as independent variables.

  week 6

• Percentage change in LDL-C levels from baseline after 6 weeks of study treatment

  EZE/ROS + CAN/AML arm vs. CAN/AML arm Percentage change in LDL-C levels from baseline after 6 weeks of study treatment For the percentage change in LDL-C levels at baseline and after 6 weeks of study treatment, the mean, standard deviation, median, minimum, and maximum will be provided by treatment arm. The LS-mean percentage change in baseline-adjusted LDL-C levels from baseline after 6 weeks of study treatment and its standard error will be provided by treatment arm. Inter-arm comparison will be conducted using the ANCOVA with percentage change in LDL-C levels as response variable and baseline LDL-C level and treatment arm as independent variables.

  week 6

Secondary Outcomes (9)

• Change in siSBP from baseline after 3 weeks of study treatment

  week 3

• Percentage changes in LDL-C levels from baseline after 3 and 6 weeks of study treatment

  week 3 and week 6

• Percentage change in LDL-C levels from baseline after 3 weeks of study treatment

  week 3

• Changes in siSBPs from baseline after 3 and 6 weeks of study treatment

  week 3 and week 6

• Percentage changes in LDL-C/HDL-C and TC/HDL-C from baseline after 3 and 6 weeks of study treatment

  week 3 and week 6

Other Outcomes (1)

• Adverse events

  Baseline, week 3 and week 6

Study Arms (3)

EZE/ROS+CAN/AML

EXPERIMENTAL

Ezetimibe/Rosuvastatin 10 mg/10 mg and Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks

Drug: Ezetimibe/Rosuvastatin

CAN/AML

ACTIVE COMPARATOR

Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg, once a day for 6 weeks

Drug: Candesartan cilexetil/Amlodipine besylate

EZE/ROS+CAN

ACTIVE COMPARATOR

Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg, once a day for 6 weeks

Drug: Candesartan cilexetil

Interventions

Ezetimibe/Rosuvastatin DRUG

Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Candesartan cilexetil 8 mg placebo

Also known as: Ezetimibe/Rosuvastatin 10 mg/10 mg

EZE/ROS+CAN/AML

Candesartan cilexetil/Amlodipine besylate DRUG

Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Ezetimibe/Rosuvastatin 10 mg/10 mg placebo + Candesartan cilexetil 8 mg placebo

Also known as: Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg

CAN/AML

Candesartan cilexetil DRUG

Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg placebo

Also known as: Candesartan cilexetil 8 mg

EZE/ROS+CAN

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to \<75 years.
• Diagnosed with essential HTN accompanied by hyperlipidemia (average siSBP ≥140 mmHg and LDL-C ≥100 mg/dL) or being treated for the condition after the diagnosis, at Visit 1 (screening).
• Provided the signed informed consent form voluntarily after receiving explanation of the objectives, methods and effects of the study.
• Medically sterile or agreed to use medically acceptable contraceptive method during the study.

You may not qualify if:

• \* Criteria Related to HTN and Dyslipidemia
• Severe HTN defined as average siDBP ≥110 mmHg or average siSBP ≥180 mmHg at Visit 1 (screening).
• The difference in BPs between those measured at both arms at Visit 1 (screening) is ≥10 mmHg for siDBP or ≥20 mmHg for siSBP.
• LDL-C \>250 mg/dL or TG ≥400 mg/dL at Visit 1 (screening).
• Diagnosed with or suspected of secondary HTN (e.g., renovascular disease, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.).
• Patients with symptomatic orthostatic HTN (difference in BPs between the value measured in supine position and the value measured in standing position is ≥20 mmHg for siSBP or ≥10 mmHg for siDBP).
• \* Criteria Related to Medical History
• Diagnosis with type 1 diabetes mellitus (DM) or uncontrolled DM (patients on insulin therapy or patients with HbA1C ≥9%).
• Patients with severe heart disease - heart failure (NYHA Classes 3 and 4), history of ischemic cardiac disease (unstable angina, myocardial infarction), peripheral vascular diseases, percutaneous transluminal angioplasty, or coronary artery bypass graft within the recent 3 months.
• Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other clinically significant arrhythmia at the discretion of the investigator.
• History of muscular toxicity while on treatment with other HMG-CoA reductase inhibitors or fibrates.
• History of angioedema while on treatment with ACE inhibitors or ARBs.
• History of hypersensitivity to ARBs, dihydropyridines, or HMG-CoA reductase inhibitors.
• Patients with hypertrophic occlusive myocardiopathy, severe occlusive coronary artery disease, aortic stenosis, hemodynamically significant aortic, or mitral valve stenosis.
• Presence of severe cerebrovascular disorders (diagnosis of stroke, cerebral infarction, or cerebral hemorrhage within the recent 6 months).

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Bundang Seoul National University Hospital

Gyeonggi-do, Seongnam-si, Bundang-gu, 13620, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Ezetimibe; Rosuvastatin Calcium; candesartan cilexetil; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Dihydropyridines; Pyridines

Study Officials

• In-Ho Chae, Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: February 20, 2019
• Study Start: July 5, 2018
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)