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OpenTrials
Completed

NCT Number: NCT02294539

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan 50mg/amlodipine 5mg

Drug

once daily, 1T, PO medication

Other names: amosartan 5/50mg

Losartan 100mg/amlodipine 5mg

Drug

once daily, 1T, PO medication

Other names: amosartan 5/100mg

Losartan 50mg/Hydrochlorothiazide 12.5mg

Drug

once daily, 1T, PO medication

Other names: Cozaar Plus

Losartan 100mg/Hydrochlorothiazide 25mg

Drug

once daily, 1T, PO medication

Other names: Cozaar Plus F

Primary outcomes

  1. change from baseline in msSBP

    Time frame: 4 weeks

Secondary outcomes

  1. change from baseline in AMcSBP

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Chong-Jin Kim

Other

Collaborators

  • Hanmi Pharmaceutical Company Limited

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2014
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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