The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.

April 9, 2013 updated by: Hanmi Pharmaceutical Company Limited

An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
  • Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
  • Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 4

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 aged or over
  • Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
  • Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)

Exclusion Criteria:

  • Patients with too high Blood pressure

    •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening

  • History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
  • Secondary hypertension or suspected to be

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amosartan® tab
Amlodipine 5mg /Losartan 100mg
Drug: Amosartan® tab
comparison of different combination of anti-hypertension drug
Other Names:
  • Amlodipine 5mg /Losartan 100mg
Active Comparator: Cozaar® plus pro tab
Losartan 100mg/ HCTZ 12.5mg
Drug: Cozaar® plus pro tab
comparison of different combination of anti-hypertension drug
Other Names:
  • Losartan 100mg/ HCTZ 12.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: Baseline, Week 8
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MSDBP
Time Frame: Baseline, week 4
Baseline, week 4
Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)
Time Frame: Baseline, Week 4 and 8
Baseline, Week 4 and 8
Blood pressure responder rate
Time Frame: Baseline, Week 4 and 8
Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg and MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.
Baseline, Week 4 and 8

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Taehoon Ahn, Ph.D., Gachon University Gil Medical Center

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, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ALOS-401

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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