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

September 21, 2015 updated by: HanAll BioPharma Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
Time Frame: Baseline and 8 week
Baseline and 8 week
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame: Baseline and 8 week
Baseline and 8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 4, 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Chang-Gyu Park, Medicine, Department of Cardiovascular, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (ESTIMATE)

March 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HATLO11III_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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