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

Sponsor

HanAll BioPharma Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01541943

Collaborator

(none)

356

Enrollment

Location

Arms

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension Hyperlipidemia	Drug: Atorvastatin Drug: Losartan Drug: Placebo Drug: HL-040XC	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

356 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HL-040XC Once daily, administered orally, 8 week	Drug: HL-040XC Once daily, administered orally, 8 week
Active Comparator: Atorvastatin Once daily, administered orally, 8 week	Drug: Atorvastatin Once daily, administered orally, 8 week Other Names: Lipitor
Active Comparator: Losartan Once daily, administered orally, 8 week	Drug: Losartan Once daily, administered orally, 8 week Other Names: Cozaar
Placebo Comparator: Placebo Once daily, administered orally, 8 week	Drug: Placebo Once daily, administered orally, 8 week

Outcome Measures

Primary Outcome Measures

Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure) [Baseline and 8 week]
Percent change from baseline to 8 week in LDL-Cholesterol [Baseline and 8 week]

Secondary Outcome Measures

Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline. [Baseline and 4, 8 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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