| Trial ID: | L2505 |
| Source ID: | NCT00157729
|
| Associated Drug: |
Pyridoxal-5'-Phosphate With And Without Ace Inhibitor
|
| Title: |
MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2|Hypertension|Metabolic Syndrome
|
| Interventions: |
DRUG: pyridoxal-5'-phosphate with and without ACE inhibitor
|
| Outcome Measures: |
Primary: Effects on blood pressure:|Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on blood pressure as measured by mean daytime ambulatory systolic blood pressure.|Effects on metabolic function:|Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on metabolic function as measured by insulinemia, fasting serum glucose, glycated hemoglobin, and triglycerides. | Secondary: To compare the effects of the different treatment regimens as measured by:|mean change from baseline in mean daytime ambulatory diastolic BP|mean change from baseline in mean 24 hour and mean night-time ambulatory systolic BP|mean changes from baseline in mean 24 hour, mean daytime and mean night-time pulse pressure|mean changes from baseline in clinic trough sitting systolic BP (SiSBP)|mean changes from baseline in mean 24 hour, and mean night-time ambulatory diastolic BP|mean changes from baseline in clinic trough sitting diastolic BP (SiDBP)|mean change in endothelial function as measured by mean changes in different markers such as ICAM-1, VCAM-1, E-selectin and albuminuria|mean changes in C-reactive protein (CRP)|mean changes in homocysteine|mean changes in creatinine
|
| Sponsor/Collaborators: |
Sponsor: Medicure
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-08
|
| Completion Date: |
2005-07
|
| Results First Posted: |
|
| Last Update Posted: |
2006-10-31
|
| Locations: |
Centre Hospitalier Université Laval, Sainte-Foy, Quebec, G1V 4G2, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00157729
|
