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
| ISRCTN | ISRCTN22416062 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22416062 |
| Secondary identifying numbers | CT/RNBX CV-LIFE/07 |
- Submission date
- 04/09/2007
- Registration date
- 06/11/2007
- Last edited
- 06/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Santosh Jha
Scientific
Scientific
Ranbaxy Laboratories Ltd
Plot-90
Sector-32
Gurgaon
122001
India
| Phone | +91 (0)991 003 4380 |
|---|---|
| dr.santoshjha@ranbaxy.com |
Study information
| Study design | Open label, prospective, non-comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RESIDD |
| Study objectives | Rosuvastatin is effective in treating high risk Indian population of diabetic patients who have abnormal lipid levels. |
| Ethics approval(s) | Ethics approval received from the Dhanvantry Independent Ethics Committee on the 11th June 2007 (ref: RANB11/06/2007). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosuvastatin |
| Primary outcome measure | 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 study start date | 15/09/2007 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/09/2007 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- India
Study participating centre
Ranbaxy Laboratories Ltd
Gurgaon
122001
India
122001
India
Sponsor information
Ranbaxy Laboratories Ltd (India)
Industry
Industry
c/o Dr Santosh Jha
Plot-90
Sector-32
Gurgaon
122001
India
| Phone | +91 (0)991 003 4380 |
|---|---|
| dr.santoshjha@ranbaxy.com | |
| Website | http://www.ranbaxy.com |
"ROR" |
https://ror.org/030yyf771 |
Funders
Funder type
Industry
Ranbaxy Laboratories Ltd (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
