Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
This study has been completed.
Sponsor:
Kowa Research Europe
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00344175
First received: June 22, 2006
Last updated: January 25, 2010
Last verified: January 2010
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Purpose
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Dyslipidemia Coronary Heart Disease |
Drug: pitavastatin Drug: simvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease |
Resource links provided by NLM:
Further study details as provided by Kowa Research Europe:
Primary Outcome Measures:
- Number of Patients Attaining NCEP LDL-C Target at Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Number of Patients Attaining NCEP LDL-C Target at Week 44 [ Time Frame: 44 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent Change From Baseline in LDL-C [ Time Frame: Baseline to 44 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 178 |
| Study Start Date: | June 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Drug: pitavastatin |
|
Active Comparator: Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
|
Drug: simvastatin |
Detailed Description:
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completed NK-104-304 (NCT 00309738)
- Hypercholesterolemia or combined dyslipidemia
- 2 or more risk factors for coronary heart disease (CHD)
Exclusion Criteria:
- Withdrawn or terminated from NK-104-304 (00309738)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344175
Locations
| Denmark | |
| Y Forskning, Bispebjerg Hospital | |
| Copenhagen Nv, Denmark | |
| Frederiks Hospital, Kardiologisk | |
| Frederiksberg, Denmark | |
| Kolesterollaboratoriet | |
| Hellerup, Denmark | |
| CCBR A/S | |
| Vejle, Denmark | |
| Netherlands | |
| Middellaan 5 | |
| Breda, Netherlands | |
| Bomanshof 8 | |
| Eindhoven, Netherlands | |
| Damsterdiep 9 | |
| Groningen, Netherlands | |
| Doezastraat 1 | |
| Leiden, Netherlands | |
| Kamerlingh Onnesstraat 16-18 | |
| Nijmegen, Netherlands | |
| Mathenesserlaan 247 | |
| Rotterdam, Netherlands | |
| Reigerstraat 30 | |
| Velp, Netherlands | |
| Parkdreef 142 | |
| Zoetermeer, Netherlands | |
| Spain | |
| Hospital Clinico S. Juan de Alicante | |
| San Juan, Alicante, Spain | |
| Hospital Universitario Reina Sofia | |
| Cordoba, Spain | |
| Fundacion Jimenez Diaz | |
| Madrid, Spain | |
| Hospital Ramon y Cajal | |
| Madrid, Spain, 28000 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain | |
| Hospital Clinico Universitario de Santiago | |
| Santiago de Compostela, Spain | |
| Sweden | |
| Angelholms Sjukhus, Medicinkliniken | |
| Angelhom, Sweden | |
| Sahlgrenska University Hospital, Intermedicin | |
| Gothenburg, Sweden | |
| Hjartmottagningen | |
| Helsingborg, Sweden | |
| Lakarcentrum Nyponet | |
| Karineholm, Sweden | |
| Medicinkliniken | |
| Ludvika, Sweden | |
| Narsjukhuset Sandviken, Kardiologlab, Medicin | |
| Sandviken, Sweden | |
| Huslakaren i Sandviken | |
| Sandviken, Sweden | |
| Hjart & Karlcenter | |
| Sodertalje, Sweden | |
| Karolinska Universitetssjukhuset | |
| Stockholm, Sweden | |
| Hjarthuset AB | |
| Varberg, Sweden | |
Sponsors and Collaborators
Kowa Research Europe
Investigators
| Study Director: | Dragos Budinski, MD | Kowa Research Europe |
More Information
No publications provided by Kowa Research Europe
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dragos Budinski, Kowa Research Europe |
| ClinicalTrials.gov Identifier: | NCT00344175 History of Changes |
| Other Study ID Numbers: | NK-104-309 |
| Study First Received: | June 22, 2006 |
| Results First Received: | September 1, 2009 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines Sweden: Medical Products Agency |
Keywords provided by Kowa Research Europe:
|
hypercholesterolemia dyslipidemia CHD pitavastatin |
simvastatin 2 or more risk factors for coronary heart disease combined dyslipidemia |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Hypercholesterolemia Dyslipidemias Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hyperlipidemias Lipid Metabolism Disorders |
Metabolic Diseases Simvastatin Pitavastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013