An investigator initiated, multicentre, randomised double blind factorial trial to assess the effectiveness and tolerability of low-dose combination BP and cholesterol lowering therapy with placebo and standard therapy in patients with migraine.

The George Institute for Global Health0 个研究点目标入组 180 人开始时间: 2016年7月14日最近更新: 2020年1月13日

适应症

试验速览

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•Migraine headache (with or without typical aura) according to the diagnostic criteria of the International Headache Society (IHS)
•* 2-14 days per month with migraine headache averaged over past 3 months (90-days), as self-reported by subject
•* Migraine symptoms must have been present for greater than or equal to 1 year prior to enrolment in the study.
•* Onset of migraine symptoms must have occurred before the age of 50 years
•* Adults between 18 and 65 years
•* Office SBP greater than or equal to 130mmHg and DBP greater than or equal 80 mmHg
•* No definite contraindications to any of the study medications at the doses used in this trial. (Subjects can be taking other preventive and therapeutic medications as long as they do not contraindicate study medication. Patients will not be eligible if they are taking medications from the same class as the study treatments)
•* Is medically stable as determined by the Study Investigator
•* If taking any concomitant migraine preventative medication(s), is on a stabilised dosage at the discretion of the Investigator
•* Is willing to stay on current migraine preventative medication(s) for the duration of the study
•* Is able to take oral medication, adhere to the medication regimens, and perform study procedures over the study duration.

•* Contraindication to any of telmisartan, amlodipine, indapamide, rosuvastatin, ezetimibe, simvastatin or propranolol
•* Concomitantly taking an angiotensin receptor blocker, angiotensin converting enzyme inhibitor, calcium channel blocker, diuretic or statin.
•* Definite indication to any one or more of the study medications
•* Subject has history of cluster headaches
•* Subject who exclusively has migraine aura without headache, migraine with brainstem aura, hemiplegic migraine or chronic migraine
•* Medication overuse headaches according to International Headache Society criteria
•* Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children.
•* Chronic medical illnesses (e.g. lupus) that could potentially affect frequency of headache as determined by the Study Investigator
•* Alcohol or substance abuse within the last year
•* Any concurrent medical or psychiatric condition which, in the investigator's judgment, may interfere with study conduct or which contraindicates participation
•* Abnormal creatinine, urea or electrolytes on screening.
•* Inability to provide informed consent.
•* Participation in a concurrent interventional medical investigation or clinical trial. Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

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