Back to resultsOlmesartan in Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo
olmesartan medoxomil
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility 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
Sites / Locations
- Result Cro
- INPUT GmbG
- Biokos Farma s.r.l.
- IMRO TRAMARKO International bv
- EUROTRIALS Lda
- Phidea S.L.
- PFC Pharma Focus Consultants AG
- Inveresk Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
2 week placebo run-in
Olmesartan medoxomil tablets for 8 weeks
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
Outcomes
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.
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.
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185172
Brief Title
Olmesartan in Essential Hypertension
Official Title
Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sankyo Pharma Gmbh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To test the efficacy and safety of olmesartan in patients with essential hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
2 week placebo run-in
Arm Title
2
Arm Type
Experimental
Arm Description
Olmesartan medoxomil tablets for 8 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo oral tablets for 2 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
olmesartan medoxomil oral tablets for 8 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
Intervention Description
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Michael Bohm, MD
Organizational Affiliation
Universitatskliniken des Saarlandes, Homburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Result Cro
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
INPUT GmbG
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Biokos Farma s.r.l.
City
Bologna
ZIP/Postal Code
40122
Country
Italy
Facility Name
IMRO TRAMARKO International bv
City
Berghem
ZIP/Postal Code
5352
Country
Netherlands
Facility Name
EUROTRIALS Lda
City
Lisboa
ZIP/Postal Code
1070-274
Country
Portugal
Facility Name
Phidea S.L.
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Facility Name
PFC Pharma Focus Consultants AG
City
Zurich
State/Province
Volketswil
ZIP/Postal Code
8604
Country
Switzerland
Facility Name
Inveresk Ltd.
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
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Olmesartan in Essential Hypertension
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