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Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00942344
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : July 20, 2009
Information provided by:
Hanmi Pharmaceutical Company Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine plus Losartan Drug: Amlodipine Drug: Losartan Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Amlodipine plus Losartan
    amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg
    Other Name: Amosartan
    Drug: Amlodipine
    amlodipine 5mg, 10mg
    Drug: Losartan
    Losartan 50mg, 100mg

Primary Outcome Measures :
  1. Average changes from baseline in sitDBP [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Average changes from baseline in sitDBP [ Time Frame: Week 4 ]
  2. Average changes from baseline in sitSBP [ Time Frame: Week 4, 8 ]
  3. Blood pressure responder rate [ Time Frame: Week 4, 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942344

Korea, Republic of
14 sites in Korea
Seoul, Busan, etc., Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Principal Investigator: Seung-Yun Cho, M.D., Ph.D. Severance Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT00942344     History of Changes
Other Study ID Numbers: HM-ALOS-201
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Hanmi Pharmaceutical Company Limited:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists