Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine 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: NCT00940667
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

July 14, 2009
July 16, 2009
October 12, 2016
May 2008
December 2008   (Final data collection date for primary outcome measure)
Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 8 ]
Same as current
Complete list of historical versions of study NCT00940667 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension
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
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Amlodipine plus Losartan
    amlodipine/losartan 5/50mg q.d.
    Other Name: Amosartan
  • Drug: Amlodipine
    amlodipine 5mg q.d.
    Other Name: Amodpine
  • Experimental: amlodipine/losartan 5/50mg
    Intervention: Drug: Amlodipine plus Losartan
  • Active Comparator: amlodipine 5mg
    Intervention: Drug: Amlodipine
Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong JW, Yoon JH, Park SH, Kwon J, Cho SY. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority study. Clin Ther. 2011 Dec;33(12):1953-63. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2. Erratum in: Clin Ther. 2012 Aug;34(8):1844. Jung, Jin Won [corrected to Jeong, Jin Won].

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Seung-Yun Cho, M.D., Ph.D. Severance Hospital
Hanmi Pharmaceutical Company Limited
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP