Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000473460
Ethics application status
Approved
Date submitted
2/09/2007
Date registered
21/09/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to evaluate the efficacy and safety of rosuvastatin in indian population who have diabetes with abnormal lipid levels (dyslipidemia)
Scientific title
An Open-Label, Prospective, Non-Comparative Clinical Trial To Evaluate The Efficacy And Safety of Rosuvastatin In High Risk Indian Population With Diabetes and Dyslipidemia by evaluating the efficacy of Rosuvastatin in changing the Total Cholesterol, Low Density Lipoprotein, High Denisty Lipoprotein, and Triglycerides in Diabetic patients who have altered lipid levels (Dyslipidemia)
Universal Trial Number (UTN)
Trial acronym
RESIDD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia in patients with Diabetes Mellitus 2328 0
Condition category
Condition code
Cardiovascular 2431 2431 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rosuvastatin 10 mg once a day for first 6 weeks and if the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guideline of Low Density Lipoprotein - Cholesterol (LDL-C) of less than 100 mg/dl is not achieved then the dose will be increased to 20 mg once a day for another 6 weeks
Intervention code [1] 2045 0
Treatment: Drugs
Comparator / control treatment
Non Comparative
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3327 0
Outcome will be measured by evaluating the blood samples of patients at Baseline, Week 6 and Week 12.
We will evaluate the mean change in the Total Cholesterol, Low Density Lipoprotein, High Denisty Lipoprotein, Triglycerides levels.
Timepoint [1] 3327 0
Baseline, Week 6 and Week 12
Secondary outcome [1] 5539 0
Mean Change in high sensitive-C-Reactive Protein, apoprotein B, apoB/apoA1 ratio, apoprotein A1, lipoprotein a and glycosylated hemoglobine
Timepoint [1] 5539 0
Baseline, Week 6 and Week 12

Eligibility
Key inclusion criteria
Diabetes Type II defined by American Diabetes Association (ADA) criteria of fasting venous plasma glucose of = 126 mg/dl, 2 hour post prandial plasma glucose of = 200 mg/dl or already on treatment of diabetes.
• Dyslipidemia defined by LDL Cholesterol more than 100 mg/dl or on prior statin therapy.
• Age of = 30 and = 70 years
• Informed consent by the patient.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Failure to give informed consent
• A history of hypersensitivity to statins
• Evidence of Fundoscopy grade 2 hypertensive or diabetic retinopathy
• Serum creatinine > 1.5 mg/dl
• Overt Proteinuria
• Pregnant or lactating mothers
• Evidence / History of Heart Failure
• Systolic Blood Pressure above 180 mmHg and Diastolic Blood Pressure above 110 mmHg
• Recent history of Cerebrovascular disease, myocardial infarction, unstable angina, new onset LBBB in the past 4 weeks
• Documented case of homozygous familial hypercholesterolemia
• Type I Diabetes Mellitus
• Use of concomitant medications (cyclosporine, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concernRecent ongoing inter current infection / hs CRP > 10 mg/L
• Active liver disease or hepatic dysfunction (defined as alanine aminotransferase (ALT), aspartate aminotransferase, alkaline phosphate or bilirubin levels = 1.5 the upper limit of normal
• Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
• Patients having history suggestive of myalgia / myositis / arthralgia
• Serious or unstable medical or psychological condition that could compromise the patient’s safety or successful trial participation
• History of alcohol consumption > 2 drinks/day (30 ml) or 10 drinks per week

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 582 0
India
State/province [1] 582 0
Country [2] 583 0
India
State/province [2] 583 0

Funding & Sponsors
Funding source category [1] 2585 0
Commercial sector/Industry
Name [1] 2585 0
Ranbaxy Laboratories Ltd
Country [1] 2585 0
India
Primary sponsor type
Commercial sector/Industry
Name
Ranbaxy Laboratories Ltd
Address
Plot-90, Sector-32, Gurgaon, Haryana
Country
India
Secondary sponsor category [1] 2337 0
None
Name [1] 2337 0
Address [1] 2337 0
Country [1] 2337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4508 0
Dhanvantri Independant Ethics Committee
Ethics committee address [1] 4508 0
Ethics committee country [1] 4508 0
India
Date submitted for ethics approval [1] 4508 0
05/06/2007
Approval date [1] 4508 0
11/06/2007
Ethics approval number [1] 4508 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28022 0
Address 28022 0
Country 28022 0
Phone 28022 0
Fax 28022 0
Email 28022 0
Contact person for public queries
Name 11179 0
Santosh Jha
Address 11179 0
Plot-90, Sector-32, Gurgaon, Haryana
Country 11179 0
India
Phone 11179 0
919910034380
Fax 11179 0
Email 11179 0
dr.santoshjha@ranbaxy.com
Contact person for scientific queries
Name 2107 0
Santosh Jha
Address 2107 0
Plot-90, Sector-32, Gurgaon, Haryana
Country 2107 0
India
Phone 2107 0
919910034380
Fax 2107 0
Email 2107 0
dr.santoshjha@ranbaxy.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.