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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine plus Losartan
Amlodipine
Losartan
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Amlodipine, Losartan, Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 14 sites in Korea

Outcomes

Primary Outcome Measures

Average changes from baseline in sitDBP

Secondary Outcome Measures

Average changes from baseline in sitDBP
Average changes from baseline in sitSBP
Blood pressure responder rate

Full Information

First Posted
July 17, 2009
Last Updated
July 17, 2009
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00942344
Brief Title
Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Amlodipine, Losartan, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amlodipine plus Losartan
Other Intervention Name(s)
Amosartan
Intervention Description
amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
amlodipine 5mg, 10mg
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Losartan 50mg, 100mg
Primary Outcome Measure Information:
Title
Average changes from baseline in sitDBP
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Average changes from baseline in sitDBP
Time Frame
Week 4
Title
Average changes from baseline in sitSBP
Time Frame
Week 4, 8
Title
Blood pressure responder rate
Time Frame
Week 4, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Yun Cho, M.D., Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
14 sites in Korea
City
Seoul, Busan, etc.
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22217192
Citation
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.
Results Reference
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Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

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