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Trial record 55 of 100 for:    AMLODIPINE AND VALSARTAN

Study to Evaluate the Safety and Efficacy of CJ-30060 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: NCT03536598
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia

Condition or disease Intervention/treatment Phase
Hypertension With Hyperlipidemia Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg Drug: Amlodipine 10 mg + Valsartan 160 mg Drug: Valsartan 160 mg + Rosuvastatin 20 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 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 III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
Actual Study Start Date : October 14, 2016
Actual Primary Completion Date : September 4, 2017
Actual Study Completion Date : September 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
Active Comparator: Reference 1
Amlodipine 10mg + Valsartan 160mg
Drug: Amlodipine 10 mg + Valsartan 160 mg
Active Comparator: Reference 2
Valsartan 160mg + Rosuvastatin 20mg
Drug: Valsartan 160 mg + Rosuvastatin 20 mg



Primary Outcome Measures :
  1. Change of LDL-C and siSBP [ Time Frame: baseline and 8 weeks ]
    Mean change from baseline in LDL-C and siSBP at Week 8



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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
  • Patient with dyslipidemia and hypertension

Exclusion Criteria:

  • At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
  • At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
  • Secodary hypertension
  • Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

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): NCT03536598


Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
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Principal Investigator: Dong Ju Choi, Ph.D Seoul National University Bundang Hospital

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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT03536598     History of Changes
Other Study ID Numbers: CJ_EXR_301
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: July 2017

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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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Amlodipine
Valsartan
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
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