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Trial record 29 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT02294539
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Hanmi Pharmaceutical Company Limited
Information provided by (Responsible Party):
Chong-Jin Kim, Kyung Hee University Hospital at Gangdong

Brief Summary:
The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics

Condition or disease Intervention/treatment Phase
Hypertension Drug: Losartan 50mg/amlodipine 5mg Drug: Losartan 100mg/amlodipine 5mg Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg Drug: Losartan 100mg/Hydrochlorothiazide 25mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Effects Between Calcium Channel Blocker and Diuretics in Combination With Angiotensin II Receptor Blocker on 24-hr Central Blood Pressure and Vascular Hemodynamic Parameters in Hypertensive Patients Multicenter, Double-blind, Active-controlled, Phase 4 Randomized Trial
Study Start Date : August 2014
Actual Primary Completion Date : May 18, 2016
Actual Study Completion Date : May 18, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Losartan 50mg/amlodipine 5mg
Once daily, 1T, PO medication
Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg
once daily, 1T, PO medication
Other Name: Cozaar Plus

Experimental: Losartan 100mg/amlodipine 5mg
Once daily, 1T, PO medication
Drug: Losartan 100mg/Hydrochlorothiazide 25mg
once daily, 1T, PO medication
Other Name: Cozaar Plus F

Active Comparator: Losartan50 mg/Hydrochlorothiazide12.5 mg
Once daily, 1T, PO medication
Drug: Losartan 50mg/amlodipine 5mg
once daily, 1T, PO medication
Other Name: amosartan 5/50mg

Active Comparator: Losartan100 mg/Hydrochlorothiazide25 mg
Once daily, 1T, PO medication
Drug: Losartan 100mg/amlodipine 5mg
once daily, 1T, PO medication
Other Name: amosartan 5/100mg




Primary Outcome Measures :
  1. change from baseline in msSBP [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. change from baseline in AMcSBP [ Time Frame: 20 weeks ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension patients not included exclusion criteria
  • Mean seated SBP ≥140mmHg in patients with newly Diagnosed

Exclusion Criteria:

- msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit


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): NCT02294539


Locations
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Korea, Republic of
Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong-Jin Kim
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Chong-Jin Kim Kyung Hee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chong-Jin Kim, Chairman of Cardiovascular Center, Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT02294539     History of Changes
Other Study ID Numbers: KSH_AMST
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors