Olmesartan in Essential Hypertension
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: placebo (Other); olmesartan medoxomil (Drug); olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sankyo Pharma Gmbh Official(s) and/or principal investigator(s):
Prof. Michael Bohm, MD, Principal Investigator, Affiliation: Universitatskliniken des Saarlandes, Homburg, Germany
Summary
To test the efficacy and safety of olmesartan in patients with essential hypertension.
Clinical Details
Official title: Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
Secondary outcome: To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
RESULT CRO, Wien 1130, Austria
INPUT GmbG, Aachen 52074, Germany
Biokos Farma s.r.l., Bologna 40122, Italy
IMRO TRAMARKO International bv, Berghem 5352, Netherlands
EUROTRIALS Lda, LISBOA 1070-274, Portugal
PHIDEA S.L., Madrid 28002, Spain
Inveresk Ltd., Edinburgh, United Kingdom
PFC Pharma Focus Consultants AG, Zurich, Volketswil 8604, Switzerland
Additional Information
Starting date: January 2002
Ending date: June 2005
Last updated: April 28, 2008
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