Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection (ArtStiff)

• ClinicalTrials.gov Identifier: NCT00676845
• Recruitment Status: Completed
• First Posted: May 13, 2008
• Last Update Posted: December 24, 2018
• Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Information provided by (Responsible Party): Daiichi Sankyo, Inc. ( Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Metabolic Syndrome; Hypertension	Drug: olmesartan medoxomil; Drug: placebo	Phase 3

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. The change from baseline in carotid-femoral pulse wave velocity (PWV) [ Time Frame: Up to 1 year of double-blind treatment ]
2. 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 :

1. 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 ]
2. On central pulse pressure (PP) and augmentation index (AI) [ Time Frame: Up to 1 year of double-blind treatment ]
3. On common carotid stiffness, intima-media thickness (IMT), and internal diameter [ Time Frame: Up to 1 year of double-blind treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

Locations

Belgium

Ghent, Belgium

Germany

Nurnberg, Germany

Italy

Monza, Italy

Sponsors and Collaborators

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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/

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company ):

Arterial stiffness; Vascular protection

Additional relevant MeSH terms:

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