Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection
NCT ID: NCT00676845
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
133 participants
INTERVENTIONAL
2008-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
A 3-week placebo run-in period.
placebo
dosage form: tablet; frequency: daily; duration: 3 weeks
2
Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
3
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
4
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 4 weeks followed by the highest study dose for 44 weeks.
olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Interventions
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olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
placebo
dosage form: tablet; frequency: daily; duration: 3 weeks
olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years and less than or equal to 75 years
* Hypertension and metabolic syndrome defined, according to the ATP III/IDF 2005 and ESH/ESC 2007 definitions, as BP greater than or equal to 130/85 mmHg and \<150/95 mmHg (i.e. untreated high normal BP or "low range" mild hypertension) and at least 2 of the following traits at:
* Abdominal obesity (waist circumference \>102 cm for men and \>88 cm for women)
* Triglyceride level greater than or equal to 150 mg/dL
* High density lipoprotein (HDL) \<40 mg/dL for men and \<50 mg/dL for women
* Fasting blood glucose greater than or equal to 110 mg/dL and \<126 mg/dL (i.e. no type 2 diabetes)
* No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. Note: treatment with angiotensin II receptor blockers (ARB)or angiotensin-converting enzyme inhibitors (ACE) is not allowed within the last 6 months.
Exclusion Criteria
* Type 1 and type 2 diabetes
* "High range" mild hypertension (i.e. systolic blood pressure \[SBP\]: 150 - \<160 mmHg and /or diastolic blood pressure \[DBP\]: 95 - \<100 mmHg)
* Moderate (SBP: 160 - 179 mmHg and DBP: 100 - 109 mmHg), severe (SBP: greater than or equal to 180 mmHg and/or greater than or equal to 110 mmHg), or resistant (hypertension resistant to treatment)hypertension
* Secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
18 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
INDUSTRY
Responsible Party
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Locations
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Ghent, , Belgium
Nuremberg, , Germany
Monza, , Italy
Countries
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References
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Laurent S, Boutouyrie P; Vascular Mechanism Collaboration. Dose-dependent arterial destiffening and inward remodeling after olmesartan in hypertensives with metabolic syndrome. Hypertension. 2014 Oct;64(4):709-16. doi: 10.1161/HYPERTENSIONAHA.114.03282. Epub 2014 Jul 7.
Other Identifiers
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2007-003131-23 EudraCT number
Identifier Type: -
Identifier Source: secondary_id
DSE-866/47
Identifier Type: -
Identifier Source: org_study_id