Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia

Last updated: August 19, 2018
Sponsor: CJ HealthCare Corporation
Overall Status: Active - Enrolling

Phase

3

Condition

Circulation Disorders

Hypertriglyceridemia

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT03639480
CJ_EXA_301
  • Ages 19-74
  • All Genders

Study Summary

To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged between 19 and 74 years

  • Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanyinghyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)

  • Decided to participate in the study and provided signed informed consent formvoluntarily after receiving explanation of the objectives, methods, and effects of thestudy

Exclusion

Exclusion Criteria:

  • Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg atVisit 1(screening)

  • The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP

  • LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)

  • Secondary hypertension

  • Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulintherapy or patients with HbA1c ≥ 9%)

Study Design

Total Participants: 180
Study Start date:
October 13, 2017
Estimated Completion Date:
October 31, 2018

Connect with a study center

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

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