Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Amlodipine plus Losartan (Drug); Amlodipine (Drug); Losartan (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hanmi Pharmaceutical Company Limited Official(s) and/or principal investigator(s): Seung-Yun Cho, M.D., Ph.D., Principal Investigator, Affiliation: Severance Hospital
Summary
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Average changes from baseline in sitDBP
Secondary outcome: Average changes from baseline in sitDBPAverage changes from baseline in sitSBP Blood pressure responder rate
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
14 sites in Korea, Seoul, Busan, etc., Korea, Republic of
Additional Information
Starting date: May 2007
Last updated: July 17, 2009
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