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Trial record 55 of 134 for:    OLMESARTAN

A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT03009487
Recruitment Status : Unknown
Verified January 2017 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemias Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg Drug: Olmesartan 40 mg, Rosuvastatin 20mg Drug: Amlodipine/Olmesartan 10/40mg (Combination drug) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2016
Estimated Primary Completion Date : July 2017


Arm Intervention/treatment
Experimental: Amlodpine, Olmesartan, Rosuvastatin
co-administration of Olmesartan, Amlodipine and Rosuvastatin
Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg
co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg

Placebo Comparator: Olmesartan, Rosuvastatin
co-administration of Olmesartan and Rosuvastatin
Drug: Olmesartan 40 mg, Rosuvastatin 20mg
co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).

Placebo Comparator: Amlodipine, Olmesartan
co-administration of Amlodipine and and Olmesartan
Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)
co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg




Primary Outcome Measures :
  1. the change of sitSBP based on baseline between Treatment arm and control 1 arm [ Time Frame: 8 weeks ]
  2. the change of LDL-C based on baseline between Treatment arm and control2 arm [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 to 80 years
  • patients with hypertension and hyperlipidemias

Exclusion Criteria:

  • orthostatic hypotension
  • History of ventricular tachycardia, atrial fibrillation
  • uncontrolled diabetes mellitus

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): NCT03009487


Contacts
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Contact: Daewoong clinical +82-2-550-8800 ext 8800

Locations
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Korea, Republic of
Seoul national university bundang hospital Recruiting
Seoul, Korea, Republic of
Contact: Wan Huh    +82-2-550-8106    whuh408@daewoong.co.kr   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03009487     History of Changes
Other Study ID Numbers: DWJ1351003
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
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