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OpenTrials
Completed

NCT Number: NCT03536598

Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia

To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia

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Key information

Conditions

Hypertension With Hyperlipidemia

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 19 and 74 years
  • Patient with dyslipidemia and hypertension

Exclusion criteria

  • At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
  • At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
  • Secodary hypertension
  • Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

Treatment and study plan

Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Drug

Amlodipine 10 mg + Valsartan 160 mg

Drug

Valsartan 160 mg + Rosuvastatin 20 mg

Drug

Primary outcomes

  1. Change of LDL-C and siSBP

    Time frame: baseline and 8 weeks

    Mean change from baseline in LDL-C and siSBP at Week 8

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 2018
Registry last updated
May 30, 2018

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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