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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01541943
First received: February 24, 2012
Last updated: September 21, 2015
Last verified: September 2015
  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 ]

Enrollment: 356
Study Start Date: March 2012
Study Completion Date: November 2014
Primary Completion Date: November 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

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

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: September 21, 2015
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 Calcium
Losartan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 25, 2016