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

Phase 3CompletedNCT01541943

HanAll BioPharma Co., Ltd.356 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

356

Conditions

Essential Hypertension Hyperlipidemia

Interventions

AtorvastatinDRUG

Once daily, administered orally, 8 week

LosartanDRUG

Once daily, administered orally, 8 week

PlaceboDRUG

Once daily, administered orally, 8 week

HL-040XC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)

Time frame: Baseline and 8 week

Percent change from baseline to 8 week in LDL-Cholesterol

Time frame: Baseline and 8 week

Secondary Outcomes

Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.

Time frame: Baseline and 4, 8 week

Data from ClinicalTrials.gov

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