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OpenTrials
Completed

NCT Number: NCT05331014

To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

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Key information

Conditions

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

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gangdong Sacred Heart Hospital

Seoul, Korea, 134-701, South Korea

About this study

Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hypertension and dyslipidemia

Exclusion criteria

  • The subject not meet the specified msBP and LDL-C level

Treatment and study plan

LivaloVA

Drug

For 8 weeks(PO, QD)

Other names: JW0101+C2101

LivaloV

Drug

For 8 weeks(PO, QD)

Other names: JW0101+C2102

VA

Drug

For 8 weeks(PO, QD)

Other names: C2101

Primary outcomes

  1. msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect

    Time frame: week 8

    change in msSBP and LDL-C level

Secondary outcomes

  1. efficacy and safety

    Time frame: week 8

    change in msSBP and LDL-C level

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Mar 15, 2024

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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