Back to resultsEfficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine plus Losartan
Amlodipine
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 ≥ 95 mmHg for drug-naïve patient)
- Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)
Exclusion Criteria:
- mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
- mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg 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
- 13 sites in Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amlodipine/losartan 5/50mg
amlodipine 5mg
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
NCT00940667
First Posted
July 14, 2009
Last Updated
October 10, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00940667
Brief Title
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine 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 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine 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
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amlodipine/losartan 5/50mg
Arm Type
Experimental
Arm Title
amlodipine 5mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amlodipine plus Losartan
Other Intervention Name(s)
Amosartan
Intervention Description
amlodipine/losartan 5/50mg q.d.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Amodpine
Intervention Description
amlodipine 5mg 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 ≥ 95 mmHg for drug-naïve patient)
Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)
Exclusion Criteria:
mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg 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
13 sites in Korea
City
Seoul, Busan, etc.
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22136978
Citation
Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong JW, Yoon JH, Park SH, Kwon J, Cho SY. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority study. Clin Ther. 2011 Dec;33(12):1953-63. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2. Erratum In: Clin Ther. 2012 Aug;34(8):1844. Jung, Jin Won [corrected to Jeong, Jin Won].
Results Reference
derived
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Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension
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