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OpenTrials
Completed

NCT Number: NCT01764295

Clinical Study for Patients With Hypertension Associated With Dyslipidemia

The purpose of this study is to evaluate the efficacy and safety of DWJ1276

Completed

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

  • Adult male and female in between ages of 20 and 80 at the time of screening
  • Subject who can understand information provided and who can sign written consent voluntarily

Exclusion criteria

  • Patients with hypersensitivity to olmesartan and rosuvastatin
  • Pregnant or lactating women and fertile women who is not using proper contraceptive method
  • Patient with history of drug or alcohol abuse

Treatment and study plan

DWJ1276

Drug

Olmesartan

Drug

Rosuvastatin

Drug

Placebo

Drug

Primary outcomes

  1. LDL-C percent change of DWJ1276 from baseline

    Time frame: 8weeks

  2. DBP change of DWJ1276 from baseline

    Time frame: 8weeks

Secondary outcomes

  1. Proportion of subjects who reached LDL-C treatment goal defined by NCEP ATP III guideline

    Time frame: 8weeks

  2. Proportion of subjects who reached blood pressure treatment goal defined by JNC VII report

    Time frame: 8weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Aug 23, 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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