Olmesartan in Essential Hypertension

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the efficacy and safety of olmesartan in patients with essential hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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