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Olmesartan in Essential Hypertension

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ClinicalTrials.gov 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

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
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT00185172

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
Principal Investigator: Prof. Michael Bohm, MD Universitatskliniken des Saarlandes, Homburg, Germany

Responsible Party: Senior Manager Study Coordinator, Daiichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00185172     History of Changes
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:
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