Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia

NCT ID: NCT01541943

Last Updated: 2015-09-23

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

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia

Detailed Description

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Conditions

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Essential Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HL-040XC

Once daily, administered orally, 8 week

Group Type EXPERIMENTAL

HL-040XC

Intervention Type DRUG

Once daily, administered orally, 8 week

Atorvastatin

Once daily, administered orally, 8 week

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Once daily, administered orally, 8 week

Losartan

Once daily, administered orally, 8 week

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Once daily, administered orally, 8 week

Placebo

Once daily, administered orally, 8 week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily, administered orally, 8 week

Interventions

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Atorvastatin

Once daily, administered orally, 8 week

Intervention Type DRUG

Losartan

Once daily, administered orally, 8 week

Intervention Type DRUG

Placebo

Once daily, administered orally, 8 week

Intervention Type DRUG

HL-040XC

Once daily, administered orally, 8 week

Intervention Type DRUG

Other Intervention Names

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Lipitor Cozaar

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 80 years
* History of essential hypertension and hyperlipidemia
* Able to sign informed consent

Exclusion Criteria

* At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HanAll BioPharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chang-Gyu Park, Medicine

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular, Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HATLO11III_1

Identifier Type: -

Identifier Source: org_study_id

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