Olmesartan in Essential Hypertension - Full Text View

Sponsor:	Sankyo Pharma Gmbh
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00185172

Purpose

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

Condition	Intervention	Phase
Essential Hypertension	Other: placebo Drug: olmesartan medoxomil Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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. [ Time Frame: From week 8 to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	2333
Study Start Date:	January 2002
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 2 week placebo run-in	Other: placebo Placebo oral tablets for 2 weeks
2: Experimental Olmesartan medoxomil tablets for 8 weeks	Drug: olmesartan medoxomil olmesartan medoxomil oral tablets for 8 weeks
3: Experimental Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks	Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185172

Locations

Austria
RESULT CRO
Wien, Austria, 1130
Germany
INPUT GmbG
Aachen, Germany, 52074
Italy
Biokos Farma s.r.l.
Bologna, Italy, 40122
Netherlands
IMRO TRAMARKO International bv
Berghem, Netherlands, 5352
Portugal
EUROTRIALS Lda
LISBOA, Portugal, 1070-274
Spain
PHIDEA S.L.
Madrid, Spain, 28002
Switzerland, Volketswil
PFC Pharma Focus Consultants AG
Zurich, Volketswil, Switzerland, 8604
United Kingdom
Inveresk Ltd.
Edinburgh, United Kingdom

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

Principal Investigator:

Prof. Michael Bohm, MD

Universitatskliniken des Saarlandes, Homburg, Germany

More Information

No publications provided

Responsible Party:	Daiichi Sankyo Europe, GmbH ( Senior Manager Study Coordinator )
Study ID Numbers:	SP-OLM-01-00
Study First Received:	September 12, 2005
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00185172 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010