The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
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ClinicalTrials.gov Identifier: NCT01828359 |
Recruitment Status :
Completed
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Amosartan® tab Drug: Cozaar® plus pro tab | Phase 4 |
- 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 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

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 |
- Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline, Week 8 ]
- Change from baseline in MSDBP [ Time Frame: Baseline, week 4 ]
- Change from baseline Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT01828359
Principal Investigator: | Taehoon Ahn, Ph.D. | Gachon University Gil Medical Center |
Responsible Party: | Hanmi Pharmaceutical Company Limited |
ClinicalTrials.gov Identifier: | NCT01828359 |
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 |
Hypertension Vascular Diseases Cardiovascular Diseases Losartan Amlodipine Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |