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

This study has been completed.

Sponsor:

Information provided by:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT00940667

First received: July 14, 2009

Last updated: July 15, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2009

Last Updated Date

July 15, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00940667 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in mean sitting diastolic blood pressure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Change from baseline in mean sitting systolic blood pressure [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
Responder rate [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Amlodipine plus Losartan
amlodipine/losartan 5/50mg q.d.

Other Name: Amosartan
Drug: Amlodipine
amlodipine 5mg q.d.

Other Name: Amodpine

Study Arm (s)

Experimental: amlodipine/losartan 5/50mg
Intervention: Drug: Amlodipine plus Losartan
Active Comparator: amlodipine 5mg
Intervention: Drug: Amlodipine

Publications *

Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jung 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. Epub 2011 Dec 2.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

185

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00940667

Other Study ID Numbers ^ICMJE

HM-ALOS-301

Has Data Monitoring Committee

Responsible Party

Director, Hanmi Pharmaceutical Company Limited

Study Sponsor ^ICMJE

Hanmi Pharmaceutical Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Seung-Yun Cho, M.D., Ph.D.

Severance Hospital

Information Provided By

Hanmi Pharmaceutical Company Limited

Verification Date

July 2009

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

To Top