Contact information
Type
Scientific
Primary contact
Dr Santosh Jha
ORCID ID
Contact details
Ranbaxy Laboratories Ltd
Plot-90
Sector-32
Gurgaon
122001
India
+91 (0)991 003 4380
dr.santoshjha@ranbaxy.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CT/RNBX CV-LIFE/07
Study information
Scientific title
Acronym
RESIDD
Study hypothesis
Rosuvastatin is effective in treating high risk Indian population of diabetic patients who have abnormal lipid levels.
Ethics approval
Ethics approval received from the Dhanvantry Independent Ethics Committee on the 11th June 2007 (ref: RANB11/06/2007).
Study design
Open label, prospective, non-comparative clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetes patients with dyslipidemia
Intervention
Once the enrolment of the patient is through he will be kept on:
1. Tab. rosuvastatin 10 mg once a day if his LDL level ranges between 100 mg/dL to 130 mg/dL for first 6 weeks, or
2. Tab. rosuvastatin 20 mg once a day if his LDL level is above 130 mg/dL for first 6 weeks
Week 6 (first follow-up):
The patients lipid profile will be evaluated and if the patients LDL does not come under 100 mg/dL as per the guidelines of National Cholesterol Education Program (NCEP)-Adult Treatment Panel (ATP) III then the dose will be doubled, i.e., patients on rosuvastatin 10 mg will receive rosuvastatin 20 mg and patients getting rosuvastatin 20 mg will be given rosuvastatin 40 mg. It will remain once a day therapy.
Week 12 (second and last follow-up - end of study):
Patients blood will be evaluated for the endpoints and the continuation of therapy will be on the treating clinician.
Intervention type
Drug
Phase
Not Specified
Drug names
Rosuvastatin
Primary outcome measures
1. Mean change in total cholesterol
2. Mean change in LDL cholesterol
3. Mean change in High Density Lipoprotein (HDL) cholesterol
4. Mean change in triglycerides
5. Number of patients achieving ATP III target LDL of less than 100 mg/dl
Primary and secondary time points will be measured by evaluating the blood parameters on week 6 and week 12 against the baseline collected at the time of enrolment.
Secondary outcome measures
1. Mean change in the level of hs-CRP
2. Mean change in level of apoprotein B
3. Mean change in apoB/apoA1 ratio
4. Mean change in apoprotein A1
5. Mean change in lipoprotein a
6. Change in glycosylated haemoglobin at the end of study period
7. Incidence of hepatic dysfunction defined by liver enzyme elevation more than three times in the absence of other systemic cause
8. Compliance and side effects
9. Mean change in the level of creatinine kinase
Primary and secondary time points will be measured by evaluating the blood parameters on week 6 and week 12 against the baseline collected at the time of enrolment.
Overall trial start date
15/09/2007
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diabetes type II defined by American Diabetes Association criteria of fasting venous plasma glucose of greater than or equal to 126 mg/dl, two-hour post prandial plasma glucose of greater than or equal to 200 mg/dl or already on treatment of diabetes
2. Dyslipidemia defined by Low Density Lipoprotein (LDL) cholesterol more than 100 mg/dl or on prior statin therapy
3. Age of greater than or equal to 30 and less than or equal to 70 years
4. Informed consent by the patient
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360
Participant exclusion criteria
1. Failure to give informed consent
2. A history of hypersensitivity to statins
3. Evidence of fundoscopy grade 2 hypertensive or diabetic retinopathy
4. Serum creatinine greater than 1.5 mg/dl
5. Overt proteinuria
6. Pregnant or lactating mothers
7. Evidence/history of heart failure
8. Systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg
9. Recent history of cerebrovascular disease, myocardial infarction, unstable angina, new onset Left Bundle Branch Block (LBBB) in the past 4 weeks
10. Documented case of homozygous familial hypercholesterolemia
11. Type I Diabetes Mellitus (DM)
12. Use of concomitant medications (cyclosporin, systemic itraconazole or ketoconazole, erythromycin, or clarithromycin, glucocorticoids or verapamil) known to affect the lipid profile or with potency safety concern
13. Recent ongoing inter-current infection/high sensitivity C-Reactive Protein (hsCRP) greater than 10 mg/L
14. Active liver disease or hepatic dysfunction (defined as Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Gamma-Glutamyl Transferase [GGT], alkaline phosphate or bilirubin levels greater than or equal to 1.5 the upper limit of normal)
15. Diagnosed to have any other endocrinal or metabolic disease other than Type II DM that is known to influence serum lipids and lipoproteins
16. Patients having history suggestive of myalgia/myositis/arthralgia
17. Serious or unstable medical or psychological condition that could compromise the patients safety or successful trial participation
18. History of alcohol consumption greater than 2 drinks/day (30 ml) or 10 drinks per week
Recruitment start date
15/09/2007
Recruitment end date
01/01/2008
Locations
Countries of recruitment
India
Trial participating centre
Ranbaxy Laboratories Ltd
Gurgaon
122001
India
Sponsor information
Organisation
Ranbaxy Laboratories Ltd (India)
Sponsor details
c/o Dr Santosh Jha
Plot-90
Sector-32
Gurgaon
122001
India
+91 (0)991 003 4380
dr.santoshjha@ranbaxy.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Ranbaxy Laboratories Ltd (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary