IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection (ArtStiff)
This study has been completed.
Sponsor:
Daiichi Sankyo Europe, GmbH
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH )
ClinicalTrials.gov Identifier:
NCT00676845
First received: May 8, 2008
Last updated: April 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome
| Condition | Intervention | Phase |
|---|---|---|
| Metabolic Syndrome Hypertension | Drug: olmesartan medoxomil Drug: placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH ):
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 133 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
A 3-week placebo run-in period.
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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: NCT00676845
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676845
Locations
| Belgium | |
| Ghent, Belgium | |
| Germany | |
| Nurnberg, Germany | |
| Italy | |
| Monza, Italy | |
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo Europe, GmbH |
| ClinicalTrials.gov Identifier: | NCT00676845 History of Changes |
| Other Study ID Numbers: |
DSE-866/47 2007-003131-23 EudraCT number |
| Study First Received: | May 8, 2008 |
| Last Updated: | April 26, 2012 |
Keywords provided by Daiichi Sankyo Inc. ( Daiichi Sankyo Europe, GmbH ):
|
Arterial stiffness Vascular protection |
Additional relevant MeSH terms:
|
Syndrome Metabolic Syndrome X 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 |
ClinicalTrials.gov processed this record on July 27, 2017