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Efficacy/Safety of Amlodipine Plus Losartan Versus 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. Identifier: NCT00940680
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : July 16, 2009
Information provided by:
Hanmi Pharmaceutical Company Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine plus Losartan Drug: Losartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: amlodipine/losartan 5/100mg Drug: Amlodipine plus Losartan
amlodipine/losartan 5/100mg q.d.
Other Name: Amosartan

Active Comparator: losartan 100mg Drug: Losartan
losartan 100mg q.d.

Primary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 4 ]
  2. Change from baseline in mean sitting systolic blood pressure [ Time Frame: Week 4, 8 ]
  3. Responder rate [ Time Frame: Week 4, 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00940680

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Hanmi Pharmaceutical Company Limited Identifier: NCT00940680     History of Changes
Other Study ID Numbers: HM-ALOS-302
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 2009
Keywords provided by Hanmi Pharmaceutical Company Limited:
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists