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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01828359
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amosartan® tab Drug: Cozaar® plus pro tab Phase 4

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  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Amosartan® tab
Amlodipine 5mg /Losartan 100mg
Drug: Amosartan® tab
comparison of different combination of anti-hypertension drug
Other Name: 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 Name: Losartan 100mg/ HCTZ 12.5mg

Primary Outcome Measures :
  1. Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline, Week 8 ]

Secondary Outcome Measures :
  1. Change from baseline in MSDBP [ Time Frame: Baseline, week 4 ]
  2. Change from baseline Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline, Week 4 and 8 ]
  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01828359

Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Principal Investigator: Taehoon Ahn, Ph.D. Gachon University Gil Medical Center

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01828359     History of Changes
Other Study ID Numbers: HM-ALOS-401
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists