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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940667
First Posted: July 16, 2009
Last Update Posted: October 12, 2016
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.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.

Condition Intervention Phase
Hypertension Drug: Amlodipine plus Losartan Drug: Amlodipine 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 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine 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: 185
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine/losartan 5/50mg Drug: Amlodipine plus Losartan
amlodipine/losartan 5/50mg q.d.
Other Name: Amosartan
Active Comparator: amlodipine 5mg Drug: Amlodipine
amlodipine 5mg q.d.
Other Name: Amodpine

  Eligibility

Information from the National Library of Medicine

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

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 ≥ 95 mmHg for drug-naïve patient)
  • Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

Exclusion Criteria:

  • mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
  • mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg 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
  Contacts and Locations
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): NCT00940667


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT00940667     History of Changes
Other Study ID Numbers: HM-ALOS-301
First Submitted: July 14, 2009
First Posted: July 16, 2009
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Hanmi Pharmaceutical Company Limited:
Amlodipine
Losartan
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
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