MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics) (NCT00157729) | Clinical Trial Compass
CompletedPhase 2
MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)
Canada160 participantsStarted 2004-08
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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), ex…
What they're measuring
1
Effects on blood pressure:
2
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.
3
Effects on metabolic function:
4
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.