Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299169
Status:
TERMINATED
Last Update Posted:
2008-01-08
First Post:
2006-03-02
Brief Title:
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient recruitmentenrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who are intolerant of statins in routine practice but who lack objective evidence of significant harm will be randomized to receive statins by either n of 1 trials or standard practice Our hypothesis is that n of 1 trials will improve statin adherence thereby improving low density lipoprotein cholesterol LDL-C levels
Detailed Description:
Cholesterol lowering medications called statins decrease heart disease in people with diabetes but research shows that many patients are not taking these medications sometimes because of side effects In our experience the side effects attributed to statin therapy are often subjective non-specific and not associated with objective evidence for a clinically important problem The most common example is muscle cramps despite a normal CK level but other symptoms include fatigue GI intolerance and neurological symptoms
Traditionally the effects of treatments are determined using randomized controlled trials N of 1 trials minimize these biases through randomization double-blinding and multiple crossovers and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous
Patients who are intolerant of statins in routine practice but who lack objective evidence of significant harm will be randomized to receive statins by either n of 1 trials or standard practice Our hypothesis is that n of 1 trials will improve statin adherence thereby improving low density lipoprotein cholesterol LDL-C levels Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way
At the end of the study we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question
Traditionally the effects of treatments are determined using randomized controlled trials N of 1 trials minimize these biases through randomization double-blinding and multiple crossovers and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous
Patients who are intolerant of statins in routine practice but who lack objective evidence of significant harm will be randomized to receive statins by either n of 1 trials or standard practice Our hypothesis is that n of 1 trials will improve statin adherence thereby improving low density lipoprotein cholesterol LDL-C levels Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way
At the end of the study we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRF-061-05 | None | None | None |