Back to resultsEfficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
Primary Purpose
Essential Hypertension, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
Losartan
Placebo
HL-040XC
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia
Eligibility 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
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
HL-040XC
Atorvastatin
Losartan
Placebo
Arm Description
Once daily, administered orally, 8 week
Once daily, administered orally, 8 week
Once daily, administered orally, 8 week
Once daily, administered orally, 8 week
Outcomes
Primary Outcome Measures
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
Percent change from baseline to 8 week in LDL-Cholesterol
Secondary Outcome Measures
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.
Full Information
NCT ID
NCT01541943
First Posted
February 24, 2012
Last Updated
September 21, 2015
Sponsor
HanAll BioPharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01541943
Brief Title
Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HanAll BioPharma Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Hyperlipidemia
Keywords
Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL-040XC
Arm Type
Experimental
Arm Description
Once daily, administered orally, 8 week
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Once daily, administered orally, 8 week
Arm Title
Losartan
Arm Type
Active Comparator
Arm Description
Once daily, administered orally, 8 week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily, administered orally, 8 week
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Once daily, administered orally, 8 week
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Cozaar
Intervention Description
Once daily, administered orally, 8 week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, administered orally, 8 week
Intervention Type
Drug
Intervention Name(s)
HL-040XC
Intervention Description
Once daily, administered orally, 8 week
Primary Outcome Measure Information:
Title
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
Time Frame
Baseline and 8 week
Title
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame
Baseline and 8 week
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Gyu Park, Medicine
Organizational Affiliation
Department of Cardiovascular, Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
We'll reach out to this number within 24 hrs