FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01541943
Enrollment
356
Registered
2012-03-01
Start date
2012-03-31
Completion date
2014-11-30
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension, Hyperlipidemia

Keywords

Atorvastatin, Losartan, Essential Hypertension, Hyperlipidemia

Brief summary

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

Interventions

DRUGAtorvastatin

Once daily, administered orally, 8 week

DRUGLosartan

Once daily, administered orally, 8 week

DRUGPlacebo

Once daily, administered orally, 8 week

DRUGHL-040XC

Once daily, administered orally, 8 week

Sponsors

HanAll BioPharma Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)Baseline and 8 week
Percent change from baseline to 8 week in LDL-CholesterolBaseline and 8 week

Secondary

MeasureTime frame
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.Baseline and 4, 8 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026