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

This study has been completed.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited Identifier:
First received: April 7, 2013
Last updated: April 9, 2013
Last verified: April 2013
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 Intervention Phase
Drug: Amosartan® tab
Drug: Cozaar® plus pro tab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in MSDBP [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
  • Change from baseline Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline, Week 4 and 8 ] [ Designated as safety issue: No ]
  • Blood pressure responder rate [ Time Frame: Baseline, Week 4 and 8 ] [ Designated as safety issue: No ]
    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.

Enrollment: 199
Study Start Date: August 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01828359

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

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01828359     History of Changes
Other Study ID Numbers: HM-ALOS-401 
Study First Received: April 7, 2013
Last Updated: April 9, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016