Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/09/2007
Date assigned
06/11/2007
Last edited
06/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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):
Patient’s 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 patient’s 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

http://www.ranbaxy.com

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

Publication citations

Additional files

Editorial Notes