Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

NCT02205606 | Completed Phase 3

• 1 other identifier: HM-ROZE-301
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to 8 week in LDL-Cholesterol

  baseline and 8 week

Secondary Outcomes (5)

• Percent change from baseline to 4 week in LDL-Cholesterol

  baseline and 4 week

• Percentage of patients reaching treatment goals according to NCEP ATP III Guideline

  week 4, week 8

• Percent change from baseline to 4 week and 8 week in TC

  week 4, week 8

• Percent change from baseline to 4 week and 8 week in HDL-C

  week 4, week 8

• Percent change from baseline to 4 week and 8 week in TG

  week 4, week 8

Study Arms (6)

HGP0816 5mg

ACTIVE COMPARATOR

Drug: HGP0816 5mg

HGP0816 10mg

ACTIVE COMPARATOR

Drug: HGP0816 10mg

HGP0816 20mg

ACTIVE COMPARATOR

Drug: HGP0816 20mg

HCP1306 5/10mg

EXPERIMENTAL

Drug: HCP1306 5/10mg

HCP1306 10/10mg

EXPERIMENTAL

Drug: HCP1306 10/10mg

HCP1306 20/10mg

EXPERIMENTAL

Drug: HCP1306 20/10mg

Interventions

HGP0816 5mg DRUG

P.O.

HGP0816 5mg

HGP0816 10mg DRUG

P.O.

HGP0816 10mg

HGP0816 20mg DRUG

P.O.

HGP0816 20mg

HCP1306 5/10mg DRUG

P.O.

HCP1306 5/10mg

HCP1306 10/10mg DRUG

P.O.

HCP1306 10/10mg

HCP1306 20/10mg DRUG

P.O.

HCP1306 20/10mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 19 years
• Signed informed consent
• At visit 1, LDL-C ≤ 250mg/dL and Triglyceride \< 400 mg/dL
• After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride \< 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

You may not qualify if:

• Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
• Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
• Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
• CK level exceeds more than 5 times of normal upper limit
• Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
• Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
• Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

19 institutions including Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Rhee MY, Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HY, Kim HS. Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clin Ther. 2019 Dec;41(12):2571-2592. doi: 10.1016/j.clinthera.2019.10.010. Epub 2019 Nov 11.

  PMID: 31727361 DERIVED

Study Officials

• Hyo-soo Kim, MD, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: July 31, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2014-07

Locations

KR (1)