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Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab (Olmesartan 20 mg/Amlodipine 5 mg/Rosuvastatin 5 or 10 mg) in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT04120753
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: OLOMAX 20/5/5mg Drug: OLOMAX 20/5/10mg Drug: Olmesartan 20 mg/Amlodipine 5 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab (Olmesartan 20 mg/Amlodipine 5 mg/Rosuvastatin 5 or 10 mg) in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: OLOMAX 20/5/5mg
Tablets, Oral, QD

Experimental: 2 Drug: OLOMAX 20/5/10mg
Tablets, Oral, QD

Active Comparator: 3 Drug: Olmesartan 20 mg/Amlodipine 5 mg
Tablets, Oral, QD




Primary Outcome Measures :
  1. Rate of change in measured LDL-C (mLDL-C) [ Time Frame: After 8 weeks ]

Secondary Outcome Measures :
  1. Rate of change in measured LDL-C (mLDL-C) [ Time Frame: After 4 weeks ]
  2. Rate of change in cLDL-C [ Time Frame: After 4 weeks and 8 weeks ]
  3. Rate of change in lipid profile(without LDL-C) [ Time Frame: After 4 weeks and 8 weeks ]
    Total cholesterol, HDL-C, Triglyceride, mLDL-C/HDL-C ratio, hs-CRP, Apo A-1, Apo B, Apo B/Apo A-1 ratio

  4. Proportion of subjects who reached in mLDL-C < 70mg/dL [ Time Frame: After 4 weeks and 8 weeks ]
  5. Proportion of subjects who reached in mLDL-C < 100mg/dL [ Time Frame: After 4 weeks and 8 weeks ]
  6. Changes and rate of change in sitSBP [ Time Frame: After 4 weeks and 8 weeks ]
  7. Changes and rate of change in sitDBP [ Time Frame: After 4 weeks and 8 weeks ]
  8. Proportion of subjects who reached the therapeutic goal [ Time Frame: After 8 weeks ]
    sitSBP<140mmHg and sitDBP<90mmHg

  9. Changes and rate of change in glucose metabolic profile [ Time Frame: After 4 weeks and 8 weeks ]
    Fasting plasma glucose (FPG), Fructosamine, HbA1c



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Patients with hypertension
  • Persons with mLDL ≥ 130mg/dL (low risk for cardiovascular disease) or mLDL ≥ 100mg/dL (intermediate risk for cardiovascular disease)
  • Written informed consent

Exclusion Criteria:

  • Patient with hypersensitivity Olmesartan, Amlodipine, Rosuvastatin, dihydropyridine
  • Who disagreed to perform effective contraception during the clinical trial
  • Orthostatic hypotension with symptoms
  • Secondary hypertension and suspected secondary hypertension
  • Creatinine clearance < 30mL/min
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120753


Contacts
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Contact: Lee 02-550-8736 solee084@daewoong.co.kr
Contact: Shin 02-550-8442 jmshin134@daewoong.co.kr

Locations
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Korea, Republic of
Daewoong pharmatceutical Recruiting
Seoul, Korea, Republic of
Contact: Kwon    02-2059-1838    gykwon277@daewoong.co.kr   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04120753     History of Changes
Other Study ID Numbers: DWJ1351_P401
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Olmesartan
Olmesartan Medoxomil
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists