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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Amlodipine plus Losartan; Drug: Amlodipine

• Registration Number: NCT00940667
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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 available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amlodipine/losartan 5/50mg	Amlodipine plus Losartan	-
amlodipine 5mg	Amlodipine	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting diastolic blood pressure	Week 8

Secondary Outcome Measures

Name	Time	Method
Responder rate	Week 4, 8
Change from baseline in mean sitting diastolic blood pressure	Week 4
Change from baseline in mean sitting systolic blood pressure	Week 4, 8

Trial Locations

Locations (1)

13 sites in Korea; 🇰🇷 Seoul, Busan, etc., Korea, Republic of