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Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension

This study has been completed.
Information provided by:
Hanmi Pharmaceutical Company Limited Identifier:
First received: July 15, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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 Intervention Phase
Hypertension Drug: Amlodipine plus Losartan Drug: Losartan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hanmi Pharmaceutical Company Limited:

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

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

Enrollment: 142
Study Start Date: April 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00940680

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Hanmi Pharmaceutical Company Limited Identifier: NCT00940680     History of Changes
Other Study ID Numbers: HM-ALOS-302
Study First Received: July 15, 2009
Last Updated: July 15, 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 processed this record on September 19, 2017