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CompletedNCT01541943Updated Sep 23, 2015

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

A Phase 3 interventional study of Atorvastatin and Losartan in Essential Hypertension and Hyperlipidemia, sponsored by HanAll BioPharma Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by HanAll BioPharma Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Essential Hypertension
  • Hyperlipidemia

Keywords

  • Atorvastatin
  • Losartan
  • Essential Hypertension
  • Hyperlipidemia
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 356 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

HanAll BioPharma Co., Ltd. is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged between 18 and 80 years
  • History of essential hypertension and hyperlipidemia
  • Able to sign informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    HL-040XC

    Once daily, administered orally, 8 week

    Drug: HL-040XC

  • Active comparator
    Atorvastatin

    Once daily, administered orally, 8 week

    Drug: Atorvastatin

  • Active comparator
    Losartan

    Once daily, administered orally, 8 week

    Drug: Losartan

  • Placebo comparator
    Placebo

    Once daily, administered orally, 8 week

    Drug: Placebo

Interventions

  • DrugAtorvastatin

    Once daily, administered orally, 8 week

    Also known as: Lipitor

  • DrugLosartan

    Once daily, administered orally, 8 week

    Also known as: Cozaar

  • DrugPlacebo

    Once daily, administered orally, 8 week

  • DrugHL-040XC

    Once daily, administered orally, 8 week

06

What researchers measure

Primary outcomes

  1. Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)

    Time frame: Baseline and 8 week

  2. Percent change from baseline to 8 week in LDL-Cholesterol

    Time frame: Baseline and 8 week

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01541943
Lead sponsor
HanAll BioPharma Co., Ltd.
Responsible party
Sponsor
First posted
Mar 1, 2012
Start date
Mar 2012
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Sep 23, 2015

Study contacts

Chang-Gyu Park, Medicine
principal investigator · Department of Cardiovascular, Korea University Guro Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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