Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

NCT00871351 | Completed Phase 4 Results

• 1 other identifier: P06027
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values

  LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).

  End of Week 4 to Week 16 or discontinuation

Secondary Outcomes (4)

• Percent Change in LDL-C

  End of washout period to Week 16 or discontinuation

• Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values

  Week 16 or discontinuation

• Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)

  End of Week 4 to Week 16 or discontinuation

• Percent Change in Total Lipids and Hs-CRP

  End of washout to Week 16 or discontinuation

Study Arms (3)

Ezetimibe + Atorvastatin

EXPERIMENTAL

Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Drug: Ezetimibe; Drug: Atorvastatin

Atorvastatin

ACTIVE COMPARATOR

Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Drug: Atorvastatin

Rosuvastatin

ACTIVE COMPARATOR

Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Drug: Rosuvastatin

Interventions

Ezetimibe DRUG

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Also known as: SCH 058235

Ezetimibe + Atorvastatin

Atorvastatin DRUG

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Ezetimibe + Atorvastatin

Rosuvastatin DRUG

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Rosuvastatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C \<160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C \<140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C \<120 mg/dL; and for participants with history of coronary artery disease - LDL-C \<100 mg/dL.
• outpatient men or women, age 20 years and older

You may not qualify if:

• fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
• homozygous familial hypercholesterolemia.
• creatine phosphokinase (CPK) \>2 times the upper limit of normal (X ULN) at start of washout or treatment period.
• glycosylated hemoglobin (HbA1c) \>=8％ at start of washout or treatment period.
• severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X ULN at start of washout or treatment period.
• hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
• pregnant or lactating
• discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
• cyclosporine treatment
• hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
• hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
• participation in a clinical study within 4 weeks of washout
• cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.

  PMID: 24653510 RESULT

MeSH Terms

Interventions

Ezetimibe; Atorvastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 23, 2024
• Results First Posted: August 23, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share