Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942344

Enrollment

320

Registered

2009-07-20

Start date

2007-05-31

Completion date

2007-12-31

Last updated

2009-07-20

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 the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Interventions

DRUGAmlodipine plus Losartan

amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg

DRUGAmlodipine

amlodipine 5mg, 10mg

DRUGLosartan

Losartan 50mg, 100mg

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients aged between 18 and 75 * Patients with essential hypertension {95 mmHg ≤ sitDBP\< 115 mmHg at the end of placebo run-in treatment period}

Exclusion criteria

* Patients with mean sitSBP ≥ 200 mmHg * Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers * Patients with secondary hypertension or suspected secondary hypertension * Patients with malignant hypertension * Patients who have received any medications with possible interactions with study drugs * Patients with uncontrolled diabetes * Patients with severe heart disease or severe cerebrovascular disease * Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST) * Patients with a history of malignant disease * Patients with a history of autoimmune disease * Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial * Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Average changes from baseline in sitDBP	Week 8

Secondary

Measure	Time frame
Average changes from baseline in sitDBP	Week 4
Average changes from baseline in sitSBP	Week 4, 8
Blood pressure responder rate	Week 4, 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026