MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)

NCT00157729 | Completed Phase 2

• 1 other identifier: MC6021-CL-04001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus Type 2; Hypertension; Metabolic Syndrome

Keywords

Hypertension; antihypertensive agents; diabetes mellitus type 2; metabolic syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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)

Interventions

pyridoxal-5'-phosphate with and without ACE inhibitor DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus treated with diet, oral hypoglycaemic agents or insulin) for a minimum of 2 years (24 months)
• Systolic hypertension prior to entry into the washout period. At Visit 3 patients must have a mean sitting systolic blood pressure in the range of 140-180 mmHg, and a mean sitting diastolic blood pressure \<110mmHg
• A mean daytime ambulatory systolic blood pressure greater than or equal to 135 mm Hg at baseline

You may not qualify if:

• Poorly controlled type 2 diabetes mellitus (HbA1c ≥ 10%)
• Secondary hypertension of any aetiology, such as renal artery stenosis, coarctation of the aorta or pheochromocytoma
• History of malignant hypertension
• Body mass index \> 37
• Single functioning kidney
• Known sensitivity or intolerance to angiotensin-converting enzyme inhibitors
• History of angioedema
• Known syncopal disorder
• Pregnant woman or a woman of childbearing potential who is sexually active and not using an appropriate method of birth control (double barrier or oral contraceptives)
• Concomitant therapy with any antihypertensive medications, including those used for indications other than hypertension (e.g., diuretics for any reason, minoxidil for hair loss, propranolol HCl for migraine, terazosin HCl for benign prostatic hyperplasia, 5-phosphodiesterase inhibitors (Viagra, Cialis, Levitra) within 48 hours of clinic visit, ACE-inhibitors for congestive heart failure, or any agent which could cause a change in blood pressure), except for stable doses of NSAIDs, or tricyclic agents taken at bedtime. Patients who are unwilling to discontinue these medications or patients in whom the Investigator feels it is clinically inappropriate to discontinue these medications should not participate in the study
• Concomitant therapy with lithium and/or major psychotropic agents such as phenothiazines
• Concomitant therapy with oral steroids or ACTH
• Concomitant therapy with cold and/or flu medications containing sympathomimetic agents. Intermittent use of therapies containing ephedrine is permitted except within 72 hours of clinic visits for mean trough SiSBP
• Concomitant therapy with any vitamin supplement that may contain pyridoxine or pyridoxine derivative such as pyridoxal phosphate or pyridoxal
• Hypertension induced by oral contraceptives. Replacement hormones (thyroid, testosterone, estrogens) are permitted if the patient has been on a stable dose for at least three months

Sponsors & Collaborators

• Medicure: lead

Study Sites (1)

Centre Hospitalier Université Laval

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Metabolic Syndrome

Interventions

Pyridoxal Phosphate; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Pyridoxal; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yves Lacourciere, MD, FRCP

  Centre Hospitalier de l'Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2004
• Study Completion: July 1, 2005
• Last Updated: October 31, 2006

Record last verified: 2006-10

Locations

CA (1)