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

NCT00940680 | Completed Phase 3

• 1 other identifier: HM-ALOS-302
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.

Conditions

Hypertension

Keywords

Amlodipine; Losartan; hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean sitting diastolic blood pressure

  Week 8

Secondary Outcomes (3)

• Change from baseline in mean sitting diastolic blood pressure

  Week 4

• Change from baseline in mean sitting systolic blood pressure

  Week 4, 8

• Responder rate

  Week 4, 8

Study Arms (2)

amlodipine/losartan 5/100mg

EXPERIMENTAL

Drug: Amlodipine plus Losartan

losartan 100mg

ACTIVE COMPARATOR

Drug: Losartan

Interventions

Amlodipine plus Losartan DRUG

amlodipine/losartan 5/100mg q.d.

Also known as: Amosartan

amlodipine/losartan 5/100mg

Losartan DRUG

losartan 100mg q.d.

losartan 100mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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≥95mmHg for drug-naïve patient)
• Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)

You may not qualify if:

• mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
• mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

9 sites in Korea

Seoul, Daegu, Etc., South Korea

Location

Related Publications (1)

• Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY. Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):189-95. doi: 10.2165/11597410-000000000-00000.

  PMID: 22462558 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles

Study Officials

• Seung-Yun Cho, M.D., Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 16, 2009

Record last verified: 2009-07

Locations

KR (1)