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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.:
Primary Outcome Measures:
- The change from baseline in carotid-femoral pulse wave velocity (PWV) [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- On central pulse pressure (PP) and augmentation index (AI) [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]
- On common carotid stiffness, intima-media thickness (IMT), and internal diameter [ Time Frame: Up to 1 year of double-blind treatment ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. ( 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 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Daiichi Sankyo Inc.:
|
Arterial stiffness Vascular protection |
Additional relevant MeSH terms:
|
Hypertension Metabolic Syndrome X Vascular Diseases Cardiovascular Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Olmesartan medoxomil |
Olmesartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013