A Diabetes Study to Treat A Population Previously Not at Target

NCT ID: NCT00747149

Last Updated: 2011-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

Brief Summary

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This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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diabetes type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin 1

titrated

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Oral

Rosuvastatin 2

Non-titrated

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Oral

Interventions

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Rosuvastatin

Oral

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Type 2 diabetes
* Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry
* Fasting LDL-C concentration of \> 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)
* History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)

Exclusion Criteria

* If currently receiving therapy with any statin at a dose higher than listed
* Rosuvastatin (current use)
* Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment.
* Type 1 diabetes; glycated haemoglobin (HbA1c) \> 9.0%
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months)
* Resting diastolic or systolic blood pressure of \> 95 mmHg or \> 180 mmHg, respectively (in the past 2 months)
* Unexplained serum creatine kinase (CK) level \> 3 × ULN (in the past 2 months).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Meani

Role: STUDY_DIRECTOR

AstraZeneca

David Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Research Site

Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Spruce Grove, Alberta, Canada

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St. Albert, Alberta, Canada

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Chilliwack, British Columbia, Canada

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Coquitlam, British Columbia, Canada

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Delta, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Maple Ridge, British Columbia, Canada

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Penticton, British Columbia, Canada

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Victoria, British Columbia, Canada

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Portage la Prairie, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Bathurst, New Brunswick, Canada

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Woodstock, New Brunswick, Canada

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Carbonear, Newfoundland and Labrador, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Kentville, Nova Scotia, Canada

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Pubnico, Nova Scotia, Canada

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Sydney Mines, Nova Scotia, Canada

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Truro, Nova Scotia, Canada

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Aylmer, Ontario, Canada

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Bolton, Ontario, Canada

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Chatham, Ontario, Canada

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Fort Erie, Ontario, Canada

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Georgetown, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Morrisburg, Ontario, Canada

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Nepean, Ontario, Canada

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Newmarket, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Scaborough, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Smith Falls, Ontario, Canada

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St. Catharines, Ontario, Canada

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Thornhill, Ontario, Canada

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Thorold, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Welland, Ontario, Canada

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Willowdale, Ontario, Canada

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Windsor, Ontario, Canada

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Woodstock, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Kensington, Prince Edward Island, Canada

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Montague, Prince Edward Island, Canada

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Anjou, Quebec, Canada

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Dolbeau-Mistassini, Quebec, Canada

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Drummondville, Quebec, Canada

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Forestville, Quebec, Canada

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Gatineau, Quebec, Canada

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Joliette, Quebec, Canada

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L'Ile Perrot, Quebec, Canada

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La Sarre, Quebec, Canada

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Laval, Quebec, Canada

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Longueuil, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Roberval, Quebec, Canada

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Roxton Pond, Quebec, Canada

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Saint-bruno-lac-saint-jean, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Saint-Pie, Quebec, Canada

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Sainte Gedeon-de-beauce, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Moose Jaw, Saskatchewan, Canada

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Porcupine Plain, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Yorkton, Saskatchewan, Canada

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Countries

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Canada

Other Identifiers

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D3560L00072

Identifier Type: -

Identifier Source: org_study_id