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Completed

NCT Number: NCT01442987

Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.

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Key information

Conditions

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

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

16 institutions including Seoul National University 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 19 and 75 years
  • Signed informed consent

Exclusion criteria

  • At screening, SPB ≥ 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
  • Has a history of multi-drug allergy

Treatment and study plan

Irbesartan/Atorvastatin A

Drug

once daily, P.O. 8week

Other names: HCP0912 A

Irbesartan

Drug

once daily, P.O. 8week

Atorvastatin A

Drug

once daily, P.O. 8week

Placebo

Drug

once daily, P.O. 8week

Irbesartan/Atorvastatin B

Drug

once daily, P.O. 8week

Other names: HCP0912 B

Atorvastatin B

Drug

once daily, P.O. 8week

Primary outcomes

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

    Time frame: baseline and 8 week

  2. Change from baseline to 8 week in Blood Pressure.

    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 rate according to JNC VII Guideline.

    Time frame: week 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Efficacy and Safety of Coadministered Irbesartan and Atorvastatin in Patients With Hypertension and Hyperlipidemia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2011
Registry last updated
Aug 13, 2013

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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