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

HanAll Biopharma

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia; Essential Hypertension

Treatments: Drug: Placebo; Drug: Losartan; Drug: Atorvastatin; Drug: HL-040XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541943

HATLO11III_1

Details and patient eligibility

About

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

Enrollment: 356 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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356 participants in 4 patient groups, including a placebo group

HL-040XC

Experimental group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: HL-040XC

Atorvastatin

Active Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Atorvastatin

Losartan

Active Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Once daily, administered orally, 8 week

Treatment:

Drug: Placebo