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

March 14, 2017 updated by: Chong-Jin Kim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Cozaar Plus
Experimental: Losartan 100mg/amlodipine 5mg
Once daily, 1T, PO medication
Drug: Losartan 100mg/Hydrochlorothiazide 25mg
once daily, 1T, PO medication
Other Names:
  • 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 Names:
  • 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 Names:
  • amosartan 5/100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in msSBP
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in AMcSBP
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong-Jin Kim

Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Chong-Jin Kim, Kyung Hee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 18, 2016

Study Completion (Actual)

May 18, 2016

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH_AMST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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