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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541943
• Other study ID #: HATLO11III_1
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2012
• Last updated: September 21, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ? receptor blocker or HMG-CoA reductase inhibitor or component of this drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Atorvastatin
Once daily, administered orally, 8 week
• Losartan
Once daily, administered orally, 8 week
• Placebo
Once daily, administered orally, 8 week
• HL-040XC
Once daily, administered orally, 8 week

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)		Baseline and 8 week	No
Primary	Percent change from baseline to 8 week in LDL-Cholesterol		Baseline and 8 week	No
Secondary	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	No