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Sponsored by: |
Medicure |
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Information provided by: | Medicure |
ClinicalTrials.gov Identifier: | NCT00157729 |
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
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus Type 2 Hypertension Metabolic Syndrome |
Drug: pyridoxal-5'-phosphate with and without ACE inhibitor |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | July 2005 |
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 <130/80 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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
This includes, but is not limited to, hematocrit, haemoglobin or platelet count
Canada, Quebec | |
Centre Hospitalier Université Laval | |
Sainte-Foy, Quebec, Canada, G1V 4G2 |
Principal Investigator: | Yves Lacourciere, MD, FRCP | Centre Hospitalier de l'Universite Laval |
Study ID Numbers: | MC6021-CL-04001 |
Study First Received: | September 8, 2005 |
Last Updated: | October 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00157729 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Hypertension antihypertensive agents diabetes mellitus type 2 metabolic syndrome |
Pyridoxal Phosphate Vitamin B Complex Metabolic Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Trace Elements Antihypertensive Agents Protease Inhibitors Pyridoxal |
Vitamins Diabetes Mellitus, Type 2 Angiotensin-Converting Enzyme Inhibitors Pyridoxine Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Hypertension |
Pyridoxal Phosphate Vitamin B Complex Metabolic Diseases Disease Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Diabetes Mellitus Vascular Diseases Endocrine System Diseases Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Pathologic Processes Vitamins Syndrome Diabetes Mellitus, Type 2 Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Micronutrients Glucose Metabolism Disorders Hypertension |