To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

NCT04659070 | Unknown Phase 3

• 1 other identifier: HL-CDP-301
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, Randomized, double-blind, acitve-controlled, Phase 3 Clinical Trial in 8 weeks for screening, twice Investigational product administer, Follow up visit.

Conditions

Primary Hypercholesterolemia; Hypertension

Outcome Measures

Primary Outcomes (2)

• Mean sitting systolic blood pressure (MSSBP)

  MSSBP change at week 8 compared to baseline, experimental, active comparator1

  baseline, week 8

• Low density lipoprotein cholesterol (LDL-C)

  LDL-C change at week 8 compare to baseline, experimental, active comparator2

  baseline, week 8

Secondary Outcomes (8)

• Mean sitting systolic blood pressure (MSSBP)

  baseline, week 4

• Mean sitting diastolic blood pressure (MSDBP)

  baseline, week 4, week 8

• the rate of patients who have reached their target blood pressure

  week4, week8

• Percentage of LDL-C change

  baseline, week4

• LDL-C change

  baseline, week4, week8

Study Arms (3)

Experimental : Ezetimibe / Rosuvastatin + Telmisartan

EXPERIMENTAL

Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks

Drug: Experimental : Ezetimibe / Rosuvastatin + Telmisartan

Active comparator1 : Ezetimibe / Rosuvastatin

ACTIVE COMPARATOR

Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks

Drug: Active comparator1 : Ezetimibe / Rosuvastatin

Active comparator2 : Telmisartan

ACTIVE COMPARATOR

Telmisartan 80mg PO, Once daily for 8 weeks

Drug: Active comparator2 : Telmisartan

Interventions

Experimental : Ezetimibe / Rosuvastatin + Telmisartan DRUG

Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks

Experimental : Ezetimibe / Rosuvastatin + Telmisartan

Active comparator1 : Ezetimibe / Rosuvastatin DRUG

Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks

Active comparator1 : Ezetimibe / Rosuvastatin

Active comparator2 : Telmisartan DRUG

Telmisartan 80mg PO, Once daily for 8 weeks

Active comparator2 : Telmisartan

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female aged 19 to 79 years of age
• a patient with congenital hypertension and hypercholesterolemia capable of administering medicines for Clinical trials planned for this clinical trial, with the discontinuation of existing therapeutic drugs according to the section.
• A person who meets the following criteria at the time of screening (visit 1)
• MSSBP \< 180mmHg and MSDBP \< 110mmHg
• LDL-C ≤ 250 mg/dL and TG \< 400 mg/dL (based on organ clinical laboratory testing)
• A person who agrees to contraception through a medically permitted contraception method during a clinical trial period.
• Possible pregnant female test subjects: intrauterine device (IUD) or IUS (Intrauterine system), intractorine defections, double-blocking method (complex use of blocking methods such as male condoms, female condoms, uterine cervical caps, contraceptive diaphragm, contraceptive sponges)
• Male test subjects with potential pregnant spouses (including partners): hormonal contraception, intrauterine device (IUD) or IUS (Intrauterine system), intraperitoneal failure, double-blocking (male condom, female condom, uterine cervical cap, contraceptive diaphragm, and contraceptive blocking)
• Patients who have agreed in writing to voluntarily participate in this clinical trial
• Randomized(Visit 2) criteria
• If the blood pressure measured at the time of random assignment is as follows:
• \- 140mmHg ≤ MSSBP \< 180mmHg and MSDBP \< 110mmHg However, patients with diabetes or chronic neuropathy: 130mmHg ≤ MSSBP \< 180mmHg (In the case of chronic neuropathy patients, albuinuria or proteinuria history is confirmed until the time of random assignment.)
• Therapeutic Lifestyle Change (TLC) after Visit 1 A person whose LDL-C and TG values correspond to the following group-specific criteria (NCEP ATP III guideline) as the basis for organ testing at the time of random assignment.
• Group1 cardiovascular risk factor : 0\~1, LDL-C(mg/dL) : 160-250, TG(mg/dL) : \< 400
• Group2 cardiovascular risk factor : 2 ≤, 10 year risk : \< 10% LDL-C(mg/dL) : 160-250 TG(mg/dL) : \< 400 cardiovascular risk factor : 2 ≤, 10% ≤ 10 year risk ≤ 20%, LDL-C(mg/dL) : 130-250 TG(mg/dL) : \< 400

You may not qualify if:

• A person suspected of secondary hypertension or secondary hypertension (aortic stenosis, hyperaldosterone haemorrhage, renal vein stenosis, sacrosanctal hypertension, chrome-friendly cell species, Cushing syndrome, polycystic neuropathy, etc.)
• Secondary dyslipidemia patients (neurological syndrome, dysplasia, closed liver disease, Cushing syndrome, etc.)
• Standing low blood pressure patient with symptoms
• Clinically meaningful ventricular tachycardia, atrial fibrillation, atrial fibrillation, or other arrhythmia patients that the tester has determined to be clinically meaningful.
• Persons with non-post-closing myocardial disease, severe closed coronary artery disease, aortic stenosis, hemodynamically meaningful aortic valve or mitral valve stenosis.
• Patients with severe heart failure (NYHA class III: Symptoms due to mild exercise/classIV: Symptoms even when stabilized)
• A person who has one or more of the following forces within the last six months based on a screening visit (visit 1):
• Those who have received ischemic heart disease (unstable angina, myocardial infarction), peripheral vascular disease, percutaneous coronary artery extension or coronary artery bypass treatment, etc.
• Patients with severe cerebrovascular disorders (brain stroke, cerebral infarction, cerebral hemorrhage, routine ischemia, etc.)
• A person with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, etc.) and surgery (except simple appendectomy or hernia surgery) that can affect the absorption, distribution, metabolism, and excretion of drugs.
• Patients with gastrointestinal diseases such as active gastritis or duodenal ulcer within one year of screening
• A person who has a history of muscle toxicity to fibromyalgia, myopathy, rhabdomyolysis, history of hereditary muscle disease or family history, and past HMGCoA reducing enzyme inhibitor or fibrate-related drugs.
• Patients with parathyroidism
• Patients with shock
• Patients with biliary obstruction or bile congestion

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Daegu Catholic Univ Medical Center

Daegu, South Korea

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Rosuvastatin Calcium; Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Kee Sik Kim, CI

CONTACT

053-650-4455; kks7379@cu.ac.kr

Kyoung Hee Baek, PM

CONTACT

82-2-3489-6160; khbaek@hanlim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: July 15, 2020
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

KR (1)