Olmesartan in Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185172
First received: September 12, 2005
Last updated: April 28, 2008
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
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

ClinicalTrials.gov processed this record on August 18, 2014