- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942344
Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
July 17, 2009 updated by: Hanmi Pharmaceutical Company Limited
An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.
The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure.
The study will investigate the dose response relationship for the combinations and monotherapies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
320
Phase
- Phase 2
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, Busan, etc., Korea, Republic of
- 14 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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged between 18 and 75
- Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}
Exclusion Criteria:
- Patients with mean sitSBP ≥ 200 mmHg
- Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
- Patients with secondary hypertension or suspected secondary hypertension
- Patients with malignant hypertension
- Patients who have received any medications with possible interactions with study drugs
- Patients with uncontrolled diabetes
- Patients with severe heart disease or severe cerebrovascular disease
- Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
- Patients with a history of malignant disease
- Patients with a history of autoimmune disease
- Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
- Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
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: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average changes from baseline in sitDBP
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average changes from baseline in sitDBP
Time Frame: Week 4
|
Week 4
|
Average changes from baseline in sitSBP
Time Frame: Week 4, 8
|
Week 4, 8
|
Blood pressure responder rate
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
May 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
July 17, 2009
First Submitted That Met QC Criteria
July 17, 2009
First Posted (Estimate)
July 20, 2009
Study Record Updates
Last Update Posted (Estimate)
July 20, 2009
Last Update Submitted That Met QC Criteria
July 17, 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-201
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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Clinical Trials on Amlodipine plus Losartan
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Hanmi Pharmaceutical Company LimitedCompletedHealthyCzech Republic
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Hanmi Pharmaceutical Company LimitedCompletedHealthyCzech Republic
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Chong-Jin KimHanmi Pharmaceutical Company LimitedCompleted
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GlaxoSmithKlineCompleted
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Korea University Anam HospitalHanmi Pharmaceutical co., ltd.Completed
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Organon and CoCompleted
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Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
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Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of
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Hanmi Pharmaceutical Company LimitedCompleted
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Merck Sharp & Dohme LLCCompleted