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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 24, 2014
Last verified: February 2014
  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:


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: October 2014
Estimated Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 24, 2014
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014