Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157729
Status:
COMPLETED
Last Update Posted:
2006-10-31
First Post:
2005-09-08
Brief Title:
MATCHED MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics
Sponsor:
Medicure
Organization:
Medicure
Study Overview
Official Title:
Evaluation of the Effects of MC-1 Alone and in Combination With an ACE Inhibitor on Ambulatory Blood Pressure and Metabolic Function in Hypertensive Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether MC-1 alone and in combination with an ACE inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with diabetes
Detailed Description:
Hypertension is an extremely common co-morbid condition in diabetics affecting up to 11 million patients depending on obesity ethnicity and age Hypertension substantially increases the risk of both macrovascular and microvascular complications including stroke coronary artery disease peripheral vascular disease retinopathy nephropathy and possibly neuropathy
In recent years adequate data from well-designed randomized clinical trials have demonstrated the effectiveness of aggressive treatment of hypertension in reducing diabetic complications In the epidemiological UK Prospective Diabetes Study UKPDS each 10 mmHg decrease in mean systolic blood pressure was associated with reductions in risk of 12 for any complication related to diabetes 15 for deaths related to diabetes 11 for myocardial infarction and 13 for microvascular complications Currently the consensus guidelines recommend a blood pressure target of 13080 mmHg in diabetic patients with hypertension even though they recognize many people will require three or more drugs to reach this goal
MC-1 is a naturally occurring metabolite of vitamin B6 and thus has very low toxicity Evidence from pre-clinical studies suggests that MC-1 has beneficial effects on hypertension and metabolic dysfunction This trial will assess the effects of MC-1 alone and MC-1 in combination with an ACE inhibitor compared to placebo on hypertension and parameters of metabolic function in type 2 diabetic patients
In recent years adequate data from well-designed randomized clinical trials have demonstrated the effectiveness of aggressive treatment of hypertension in reducing diabetic complications In the epidemiological UK Prospective Diabetes Study UKPDS each 10 mmHg decrease in mean systolic blood pressure was associated with reductions in risk of 12 for any complication related to diabetes 15 for deaths related to diabetes 11 for myocardial infarction and 13 for microvascular complications Currently the consensus guidelines recommend a blood pressure target of 13080 mmHg in diabetic patients with hypertension even though they recognize many people will require three or more drugs to reach this goal
MC-1 is a naturally occurring metabolite of vitamin B6 and thus has very low toxicity Evidence from pre-clinical studies suggests that MC-1 has beneficial effects on hypertension and metabolic dysfunction This trial will assess the effects of MC-1 alone and MC-1 in combination with an ACE inhibitor compared to placebo on hypertension and parameters of metabolic function in type 2 diabetic patients
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