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

This study is currently recruiting participants.
Verified October 2012 by HanAll BioPharma Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01541943
First received: February 24, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HanAll BioPharma Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure) [ Time Frame: Baseline and 8 week ] [ Designated as safety issue: No ]
  • Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: Baseline and 8 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 356
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HL-040XC
Once daily, administered orally, 8 week
 Drug: HL-040XC
Once daily, administered orally, 8 week
Other Name: HL-040XC
Active Comparator: Atorvastatin
Once daily, administered orally, 8 week
 Drug: Atorvastatin
Once daily, administered orally, 8 week
Other Name: Lipitor
Active Comparator: Losartan
Once daily, administered orally, 8 week
 Drug: Losartan
Once daily, administered orally, 8 week
Other Name: Cozaar
Placebo Comparator: Placebo
Once daily, administered orally, 8 week
 Drug: Placebo
Once daily, administered orally, 8 week
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541943

Contacts
Contact: Jin Hong Park, Team manager 82-2-2204-1761 jinhong07@hanall.co.kr

Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chang Gyu Park, Medicine            
Principal Investigator: Chang Gyu Park, Medicine            
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
Principal Investigator: Chang-Gyu Park, Medicine Department of Cardiovascular, Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01541943     History of Changes
Other Study ID Numbers: HATLO11III_1
Study First Received: February 24, 2012
Last Updated: October 15, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by HanAll BioPharma Co., Ltd.:
Atorvastatin
Losartan
Essential Hypertension
Hyperlipidemia

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Losartan
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013