Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection (ArtStiff)
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ClinicalTrials.gov Identifier: NCT00676845 |
Recruitment Status :
Completed
First Posted : May 13, 2008
Last Update Posted : December 24, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome Hypertension | Drug: olmesartan medoxomil Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 133 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
A 3-week placebo run-in period.
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Drug: placebo
dosage form: tablet; frequency: daily; duration: 3 weeks |
Experimental: 2
Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
|
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks |
Experimental: 3
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
|
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks |
Experimental: 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.
|
Drug: olmesartan medoxomil
dosage form: oral tablet; frequency: daily; duration: 52 weeks |
- The change from baseline in carotid-femoral pulse wave velocity (PWV) [ Time Frame: Up to 1 year of double-blind treatment ]
- The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in mean blood pressure (MBP)as measured at the same visit [ Time Frame: Up to 1 year of double-blind treatment ]
- On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM) [ Time Frame: Up to 1 year of double-blind treatment ]
- On central pulse pressure (PP) and augmentation index (AI) [ Time Frame: Up to 1 year of double-blind treatment ]
- On common carotid stiffness, intima-media thickness (IMT), and internal diameter [ Time Frame: Up to 1 year of double-blind treatment ]

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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:
- Male and female outpatients
- 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:
- Pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception)
- 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

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): NCT00676845
Belgium | |
Ghent, Belgium | |
Germany | |
Nurnberg, Germany | |
Italy | |
Monza, Italy |
Responsible Party: | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company |
ClinicalTrials.gov Identifier: | NCT00676845 |
Other Study ID Numbers: |
DSE-866/47 2007-003131-23 EudraCT number |
First Posted: | May 13, 2008 Key Record Dates |
Last Update Posted: | December 24, 2018 |
Last Verified: | April 2012 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. |
Access Criteria: | Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Arterial stiffness Vascular protection |
Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Olmesartan Olmesartan Medoxomil Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |