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Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

NCT ID: NCT01127217

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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amlodipine/losartan

Group Type EXPERIMENTAL

amlodipine/losartan

Intervention Type DRUG

amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)

amlodipine

Group Type ACTIVE_COMPARATOR

amlodipine

Intervention Type DRUG

amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)

Interventions

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amlodipine/losartan

amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)

Intervention Type DRUG

amlodipine

amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)

Intervention Type DRUG

Other Intervention Names

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amosartan amodipin(amlodipine camsylate)

Eligibility Criteria

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Inclusion Criteria

* 18 aged or over
* Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
* Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria

* Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
* ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
* History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
* Secondary hypertension or suspected to be
* Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
* Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
* History of severe neurovascular disease, severe heart disease
* Known as moderate or malignant retinopathy.
* Renal diseases; serum creatinine ≥ 2mg/dl
* Hepatic diseases; increase in ALT or AST ≥ 2xUNL
* Anuria
* Hyponatremia/hypokalemia or hypercalcemia
* Active Gout
* Surgical or medical diseases which might significantly change ADME of medicines
* History of malignant tumor
* Autoimmune diseases
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
* Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Locations

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8 Sites

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.

Reference Type DERIVED
PMID: 22035131 (View on PubMed)

Other Identifiers

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HM-ALOS-303

Identifier Type: -

Identifier Source: org_study_id