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Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639480
Recruitment Status : Unknown
Verified August 2018 by HK inno.N Corporation.
Recruitment status was:  Enrolling by invitation
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Study Description
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Brief Summary:
To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg Drug: Amlodipine 10mg+Valsartan 160mg Drug: Valsartan 160mg+Atorvastatin 40mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Test
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
 Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Active Comparator: Reference 1
Amlodipine 10mg+Valsartan 160mg
 Drug: Amlodipine 10mg+Valsartan 160mg
Amlodipine 10mg+Valsartan 160mg
Active Comparator: Reference 2
Valsartan 160mg+Atorvastatin 40mg
 Drug: Valsartan 160mg+Atorvastatin 40mg
Valsartan 160mg+Atorvastatin 40mg


Outcome Measures
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Primary Outcome Measures :
  1. Change in siSBP [ Time Frame: baseline and 8 weeks ]
    Change in siSBP from baseline after 8 weeks of study treatment

  2. Change in LDL-C [ Time Frame: baseline and 8 weeks ]
    Change in LDL-C from baseline after 8 weeks of study treatment


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 19 and 74 years
  • Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
  • Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study

Exclusion Criteria:

  • Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
  • The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
  • LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
  • Secondary hypertension
  • Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
Contacts and Locations
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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): NCT03639480


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
HK inno.N Corporation
Investigators
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Principal Investigator: Duk-Hyun Kang, Ph.D Asan Medical Center
More Information
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT03639480    
Other Study ID Numbers: CJ_EXA_301
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

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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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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Valsartan
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists