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

NCT ID: NCT00940667

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

amlodipine/losartan 5/50mg

Group Type: EXPERIMENTAL

Amlodipine plus Losartan

Intervention Type: DRUG

amlodipine/losartan 5/50mg q.d.

amlodipine 5mg

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

amlodipine 5mg q.d.

Interventions

Amlodipine plus Losartan

amlodipine/losartan 5/50mg q.d.

Intervention Type: DRUG

Amlodipine

amlodipine 5mg q.d.

Intervention Type: DRUG

Other Intervention Names

Amosartan; Amodpine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

13 sites in Korea

Seoul, Busan, Etc., , South Korea

Countries

South Korea

References

Kang SM, Youn JC, Chae SC, Park CG, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Shin DG, Jeong 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. doi: 10.1016/j.clinthera.2011.11.007. Epub 2011 Dec 2.

Reference Type: DERIVED

PMID: 22136978 (View on PubMed)

Other Identifiers

HM-ALOS-301

Identifier Type: -

Identifier Source: org_study_id