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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01828359
First received: April 7, 2013
Last updated: April 9, 2013
Last verified: April 2013

April 7, 2013
April 9, 2013
August 2010
January 2013   (final data collection date for primary outcome measure)
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01828359 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
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.

  • 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Amosartan® tab
    comparison of different combination of anti-hypertension drug
    Other Name: Amlodipine 5mg /Losartan 100mg
  • Drug: Cozaar® plus pro tab
    comparison of different combination of anti-hypertension drug
    Other Name: Losartan 100mg/ HCTZ 12.5mg
  • Experimental: Amosartan® tab
    Amlodipine 5mg /Losartan 100mg
    Intervention: Drug: Amosartan® tab
  • Active Comparator: Cozaar® plus pro tab
    Losartan 100mg/ HCTZ 12.5mg
    Intervention: Drug: Cozaar® plus pro tab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01828359
HM-ALOS-401
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Taehoon Ahn, Ph.D. Gachon University Gil Medical Center
Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP