- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00940680
Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension
July 15, 2009 updated by: Hanmi Pharmaceutical Company Limited
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Daegu, etc., Korea, Republic of
- 9 sites in Korea
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: amlodipine/losartan 5/100mg
|
amlodipine/losartan 5/100mg q.d.
Other Names:
|
Active Comparator: losartan 100mg
|
losartan 100mg q.d.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in mean sitting diastolic blood pressure
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responder rate
Time Frame: Week 4, 8
|
Week 4, 8
|
Change from baseline in mean sitting diastolic blood pressure
Time Frame: Week 4
|
Week 4
|
Change from baseline in mean sitting systolic blood pressure
Time Frame: Week 4, 8
|
Week 4, 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seung-Yun Cho, M.D., Ph.D., Severance Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
July 15, 2009
First Submitted That Met QC Criteria
July 15, 2009
First Posted (Estimate)
July 16, 2009
Study Record Updates
Last Update Posted (Estimate)
July 16, 2009
Last Update Submitted That Met QC Criteria
July 15, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Losartan
Other Study ID Numbers
- HM-ALOS-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
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Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
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Addpharma Inc.Completed
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Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
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China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
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Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
Clinical Trials on Amlodipine plus Losartan
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Hanmi Pharmaceutical Company LimitedCompletedHealthyCzech Republic
-
Hanmi Pharmaceutical Company LimitedCompletedHealthyCzech Republic
-
Chong-Jin KimHanmi Pharmaceutical Company LimitedCompleted
-
GlaxoSmithKlineCompleted
-
Korea University Anam HospitalHanmi Pharmaceutical co., ltd.Completed
-
Organon and CoCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedCompleted
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of