Back to resultsEfficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine plus Losartan
Losartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Amlodipine, Losartan, hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years of age
- Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
- Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)
Exclusion Criteria:
- mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
- mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
- has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
- Secondary hypertensive patient or suspected to be
- Uncontrolled diabetes mellitus patients
- Severe heart disease or severe neurovascular disease
- Known as severe or malignant retinopathy
- Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
- History of malignancy tumor
- History of autoimmune disease
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, has an intention on pregnancy
- Considered by investigator as not appropriate to participate in the clinical study with othe reason
Sites / Locations
- 9 sites in Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amlodipine/losartan 5/100mg
losartan 100mg
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mean sitting diastolic blood pressure
Secondary Outcome Measures
Change from baseline in mean sitting diastolic blood pressure
Change from baseline in mean sitting systolic blood pressure
Responder rate
Full Information
NCT ID
NCT00940680
First Posted
July 15, 2009
Last Updated
July 15, 2009
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00940680
Brief Title
Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension
Official Title
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 100mg Versus Losartan 100mg in Patients With Essential Hypertension Not Controlled on Losartan Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Amlodipine, Losartan, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amlodipine/losartan 5/100mg
Arm Type
Experimental
Arm Title
losartan 100mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amlodipine plus Losartan
Other Intervention Name(s)
Amosartan
Intervention Description
amlodipine/losartan 5/100mg q.d.
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
losartan 100mg q.d.
Primary Outcome Measure Information:
Title
Change from baseline in mean sitting diastolic blood pressure
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting diastolic blood pressure
Time Frame
Week 4
Title
Change from baseline in mean sitting systolic blood pressure
Time Frame
Week 4, 8
Title
Responder rate
Time Frame
Week 4, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age
Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)
Exclusion Criteria:
mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
Secondary hypertensive patient or suspected to be
Uncontrolled diabetes mellitus patients
Severe heart disease or severe neurovascular disease
Known as severe or malignant retinopathy
Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
History of malignancy tumor
History of autoimmune disease
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, has an intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with othe reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Yun Cho, M.D., Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
9 sites in Korea
City
Seoul, Daegu, etc.
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22462558
Citation
Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY. Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):189-95. doi: 10.2165/11597410-000000000-00000.
Results Reference
derived
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Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension
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