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

A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 100mg Versus Losartan 100mg in Patients With Essential Hypertension Not Controlled on Losartan Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940680

Enrollment

142

Registered

2009-07-16

Start date

2008-04-30

Completion date

2008-11-30

Last updated

2009-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Amlodipine, Losartan, hypertension

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.

Interventions

DRUGAmlodipine plus Losartan

amlodipine/losartan 5/100mg q.d.

DRUGLosartan

losartan 100mg q.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean sitting diastolic blood pressure	Week 8

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026