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

NCT01541943 | Completed Phase 3

• 1 other identifier: HATLO11III_1
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Essential Hypertension; Hyperlipidemia

Keywords

Atorvastatin; Losartan; Essential Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• 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-Cholesterol

  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.

  Baseline and 4, 8 week

Study Arms (4)

HL-040XC

EXPERIMENTAL

Once daily, administered orally, 8 week

Drug: HL-040XC

Atorvastatin

ACTIVE COMPARATOR

Once daily, administered orally, 8 week

Drug: Atorvastatin

Losartan

ACTIVE COMPARATOR

Once daily, administered orally, 8 week

Drug: Losartan

Placebo

PLACEBO COMPARATOR

Once daily, administered orally, 8 week

Drug: Placebo

Interventions

Atorvastatin DRUG

Once daily, administered orally, 8 week

Also known as: Lipitor

Atorvastatin

Losartan DRUG

Once daily, administered orally, 8 week

Also known as: Cozaar

Losartan

Placebo DRUG

Once daily, administered orally, 8 week

Placebo

HL-040XC DRUG

Once daily, administered orally, 8 week

HL-040XC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HanAll BioPharma Co., Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension; Hyperlipidemias

Interventions

Atorvastatin; Losartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Tetrazoles

Study Officials

• Chang-Gyu Park, Medicine

  Department of Cardiovascular, Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

KR (1)