Clinical Trials Logo
  1. Home
  2. Hypercholesterolaemia
  3. NCT00328523
  4. Details
NCT00328523 Clinical Trial

TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)

Hypercholesterolaemia Clinical Trial

Official title:
Ezetimibe Together With Any Statin Cholesterol Enhancement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00328523
Other study ID # 0653-060
Secondary ID 2006_024
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2004
Est. completion date January 2006

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing statin and non drug therapeutic intervention (patient motivation on diet or physical activities or both).

Recruitment information / eligibility
Status Completed
Enrollment 1496
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Primary hypercholesterolemia treated with any statin at any dose, for at least 3 months with a ldl cholesterol above 115 mg/dl (esc 2003 recommendations). Exclusion Criteria: - pregnant or breast feeding women - Lipid-lowering agents including hmg-coa reductase inhibitors other than the current statin, fish oils, cholestyramin, niacin (>200 mg/day) and fibrates taken within the 3 months preceding visit 1.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK-0653, ezetimibe

• Duration of Treatment: 3 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Steg PG, Verdier JC, Carré F, Darne B, Ducardonnet A, Jullien G, Farnier M, Giral P, Haïat R; TWICE Investigators, France. A randomised trial of three counselling strategies for lifestyle changes in patients with hypercholesterolemia treated with ezetimib — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
Secondary Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
See also
  Status Clinical Trial Phase
Completed NCT01935674 - Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels Phase 4
Completed NCT02890992 - An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Phase 2
Completed NCT00653835 - Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435) Phase 4
Recruiting NCT06008756 - MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes Phase 3
Completed NCT02585778 - Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) Phase 3
Completed NCT00329173 - PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin. Phase 3
Completed NCT04169386 - A Study of PCSK9 Inhibitor AK102 in Healthy Subjects Phase 1
Completed NCT02770131 - Chart Review of Repatha® in Subjects With Hyperlipidaemia
Completed NCT03510884 - An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Phase 3
Recruiting NCT06275724 - Specified Drug-use Survey of Leqvio for s.c. Injection.
Completed NCT03415178 - Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy Phase 3
Completed NCT01779687 - Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin. Phase 1
Completed NCT01617655 - Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) Phase 3
Completed NCT05934292 - MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020) Phase 1
Completed NCT01257971 - Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors N/A
Completed NCT00163163 - Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women Phase 3
Completed NCT01597700 - Acotral® Versus Zetia® Ezetimibe Bioequivalance Study. Phase 1
Terminated NCT02906124 - Study to Evaluate the Safety of Repatha® in Pregnancy
Completed NCT01711749 - Rosuvastatin Calcium Bioequivalence Study - Fast Phase 1
Completed NCT02065180 - The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome Phase 4