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Olmesartan in Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185172
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 29, 2008
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Other: placebo Drug: olmesartan medoxomil Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
Study Start Date : January 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
2 week placebo run-in
Other: placebo
Placebo oral tablets for 2 weeks

Experimental: 2
Olmesartan medoxomil tablets for 8 weeks
Drug: olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks

Experimental: 3
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185172

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Result Cro
Wien, Austria, 1130
Aachen, Germany, 52074
Biokos Farma s.r.l.
Bologna, Italy, 40122
IMRO TRAMARKO International bv
Berghem, Netherlands, 5352
Lisboa, Portugal, 1070-274
Phidea S.L.
Madrid, Spain, 28002
PFC Pharma Focus Consultants AG
Zurich, Volketswil, Switzerland, 8604
United Kingdom
Inveresk Ltd.
Edinburgh, United Kingdom
Sponsors and Collaborators
Sankyo Pharma Gmbh
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Principal Investigator: Prof. Michael Bohm, MD Universitatskliniken des Saarlandes, Homburg, Germany
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Responsible Party: Senior Manager Study Coordinator, Daiichi Sankyo Europe, GmbH Identifier: NCT00185172    
Other Study ID Numbers: SP-OLM-01-00
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists