Status:
COMPLETED
Olmesartan in Essential Hypertension
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
To test the efficacy and safety of olmesartan in patients with essential hypertension.
Eligibility Criteria
Inclusion
- Age: 18 (19 if required by local authorities) to 75 years
- 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
- Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
2333 Patients enrolled
Trial Details
Trial ID
NCT00185172
Start Date
January 1 2002
End Date
June 1 2005
Last Update
April 29 2008
Active Locations (8)
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1
Result Cro
Vienna, Austria, 1130
2
INPUT GmbG
Aachen, Germany, 52074
3
Biokos Farma s.r.l.
Bologna, Italy, 40122
4
IMRO TRAMARKO International bv
Berghem, Netherlands, 5352