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Completed

NCT Number: NCT01541943

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

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Once daily, administered orally, 8 week

Other names: Lipitor

Losartan

Drug

Once daily, administered orally, 8 week

Other names: Cozaar

Placebo

Drug

Once daily, administered orally, 8 week

HL-040XC

Drug

Once daily, administered orally, 8 week

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

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 1, 2012
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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