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Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00942344
First received: July 17, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 17, 2009
July 17, 2009
May 2007
December 2007   (final data collection date for primary outcome measure)
Average changes from baseline in sitDBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Average changes from baseline in sitDBP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Average changes from baseline in sitSBP [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
  • Blood pressure responder rate [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Amlodipine plus Losartan
    amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg
    Other Name: Amosartan
  • Drug: Amlodipine
    amlodipine 5mg, 10mg
  • Drug: Losartan
    Losartan 50mg, 100mg
Not Provided
Park CG, Youn HJ, Chae SC, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Hong BK, Jeong JW, Park SH, Kwan J, Choi YJ, Cho SY. Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study. Am J Cardiovasc Drugs. 2012 Feb 1;12(1):35-47. doi: 10.2165/11597170-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged between 18 and 75
  • Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}

Exclusion Criteria:

  • Patients with mean sitSBP ≥ 200 mmHg
  • Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
  • Patients with secondary hypertension or suspected secondary hypertension
  • Patients with malignant hypertension
  • Patients who have received any medications with possible interactions with study drugs
  • Patients with uncontrolled diabetes
  • Patients with severe heart disease or severe cerebrovascular disease
  • Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
  • Patients with a history of malignant disease
  • Patients with a history of autoimmune disease
  • Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
  • Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00942344
HM-ALOS-201
No
Director, 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
July 2009

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