Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2333 participants
INTERVENTIONAL
2002-01-31
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
2 week placebo run-in
placebo
Placebo oral tablets for 2 weeks
2
Olmesartan medoxomil tablets for 8 weeks
olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
3
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
Interventions
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placebo
Placebo oral tablets for 2 weeks
olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
Eligibility Criteria
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Inclusion Criteria
* Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
* Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
* Written Informed Consent
* Mentally competent
* Negative pregnancy test in women at a childbearing age at the beginning of the study
Exclusion Criteria
* Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
* Patients with a history or current evidence of congestive heart failure
* Bilateral renal artery stenosis
* Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
* Severe hepatic impairment or biliary obstruction
18 Years
75 Years
ALL
No
Sponsors
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Sankyo Pharma Gmbh
INDUSTRY
Responsible Party
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Daiichi Sankyo Europe, GmbH
Principal Investigators
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Prof. Michael Bohm, MD
Role: PRINCIPAL_INVESTIGATOR
Universitatskliniken des Saarlandes, Homburg, Germany
Locations
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Result Cro
Vienna, , Austria
INPUT GmbG
Aachen, , Germany
Biokos Farma s.r.l.
Bologna, , Italy
IMRO TRAMARKO International bv
Berghem, , Netherlands
EUROTRIALS Lda
Lisbon, , Portugal
Phidea S.L.
Madrid, , Spain
PFC Pharma Focus Consultants AG
Zurich, Volketswil, Switzerland
Inveresk Ltd.
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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SP-OLM-01-00
Identifier Type: -
Identifier Source: org_study_id