Candesartan Versus Propranolol for Migraine Prevention
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ClinicalTrials.gov Identifier: NCT00884663 |
Recruitment Status
:
Completed
First Posted
: April 21, 2009
Last Update Posted
: December 24, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Without Aura Migraine With Aura Chronic Migraine | Drug: Candesartan Drug: propranolol Drug: placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Candesartan vs Propranolol for Migraine Prevention: A Double Blind, Placebo Controlled, Double Dummy, Triple Cross-over Study |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 Candesartan |
Drug: Candesartan
Candesartan cilexitil tablets, 16 mg once daily
|
Active Comparator: 2 propranolol |
Drug: propranolol
Propranolol hydrochloride capsules 160 mg once daily, slow release formulation
|
Placebo Comparator: 3 Placebo |
Drug: placebo
placebo tablets and capsules
|
- The number of days per 4 weeks with moderate or severe headache lasting ≥ 4 hours or is treated with the patient's usual headache medication [ Time Frame: One year ]
- Days with headache [ Time Frame: One year ]
- Hours with headache [ Time Frame: One year ]
- Headache intensity (0-3 scale) on days with headache [ Time Frame: one year ]
- Doses of analgesics [ Time Frame: one year ]
- Doses of triptans [ Time Frame: One year ]
- Days with sick leave [ Time Frame: one year ]
- Number of responders (≥ 50% decrease in migraine days compared with baseline) [ Time Frame: one year ]
- Number of reported side effects [ Time Frame: one year ]
- Number of predefined retrospective side effects [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18 to 65 years
- retrospectively have ≥ 2 migraine attacks per month during the last 3 months
- during the baseline period have ≥ 2 migraine attacks
- debut of migraine at least one year prior to inclusion
- start of migraine before age 50 years.
Exclusion Criteria:
- interval headache not distinguishable from migraine
- chronic tension-type headache or other headache occurring on ≥ 15 days/month
- pregnancy, nursing or inability to use contraceptives
- heart conduction block on ECG or significant ECG abnormality on inclusion
- heart rate < 54 after 3 minutes rest
- previous or present asthma, diabetes; decreased hepatic or renal function
- hypersensitivity to active substance
- history of angioneurotic edema
- significant psychiatric illness
- use of daily migraine prophylactics less than 4 weeks prior to start of study
- having tried ≥ 3 prophylactic drugs against migraine during the last 10 years
- previous use of propranolol or candesartan in adequate doses
- previous discontinuation of either Atacand or Inderal Retard (or another beta blocker) due to side effects
- current use of antihypertensive medication
- require use of rizatriptan (Maxalt) 10 mg tabl.
- subjects requiring detoxification from acute medication (ergotamines, opioids)
- patients who consistently fail to respond to any acute migraine medication
- patients with alcohol or illicit drug dependence

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884663
Norway | |
Norwegian National Headache Centre, St. Olavs University Hospital | |
Trondheim, Norway, 7489 |
Principal Investigator: | Lars J Stovner, Ph.D. | Norwegian National Headache Centre, St. Olavs Hospital | |
Study Director: | Lars J Stovner, Ph.D. | Norwegian National Headache Centre |
Publications of Results:
Other Publications:
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00884663 History of Changes |
Other Study ID Numbers: |
01-47-7006-2008 2008-002312-17 ( EudraCT Number ) |
First Posted: | April 21, 2009 Key Record Dates |
Last Update Posted: | December 24, 2013 |
Last Verified: | December 2013 |
Additional relevant MeSH terms:
Migraine Disorders Migraine with Aura Migraine without Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Propranolol Candesartan Candesartan cilexetil |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |