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Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 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: NCT01127217
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : September 14, 2010
Information provided by:
Hanmi Pharmaceutical Company Limited

Brief Summary:
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

Condition or disease Intervention/treatment Phase
Hypertension Drug: amlodipine/losartan Drug: amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: amlodipine/losartan Drug: amlodipine/losartan
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
Other Name: amosartan

Active Comparator: amlodipine Drug: amlodipine
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
Other Name: amodipin(amlodipine camsylate)

Primary Outcome Measures :
  1. Change from baseline in MSSBP [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures :
  1. Change from baseline in MSSBP [ Time Frame: Baseline, Week 2 and 8 ]
  2. Change from baseline MSDBP [ Time Frame: Baseline, Week 2, 6, and 8 ]
  3. Blood pressure responder rate [ Time Frame: Baseline, Week 2, 6, 8 ]
    Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.

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:

  • 18 aged or over
  • Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
  • Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

  • Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
  • ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
  • History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
  • Secondary hypertension or suspected to be
  • Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
  • Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
  • History of severe neurovascular disease, severe heart disease
  • Known as moderate or malignant retinopathy.
  • Renal diseases; serum creatinine ≥ 2mg/dl
  • Hepatic diseases; increase in ALT or AST ≥ 2xUNL
  • Anuria
  • Hyponatremia/hypokalemia or hypercalcemia
  • Active Gout
  • Surgical or medical diseases which might significantly change ADME of medicines
  • History of malignant tumor
  • Autoimmune diseases
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
  • Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision

Other protocol-defined inclusion/exclusion criteria may apply

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): NCT01127217

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Korea, Republic of
8 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01127217    
Other Study ID Numbers: HM-ALOS-303
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Keywords provided by Hanmi Pharmaceutical Company Limited:
stage 2
Additional relevant MeSH terms:
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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