search
Back to results

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

Primary Purpose

Metabolic Syndrome, Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olmesartan medoxomil
placebo
olmesartan medoxomil
olmesartan medoxomil
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Arterial stiffness, Vascular protection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

A 3-week placebo run-in period.

Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period

Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.

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.

Outcomes

Primary Outcome Measures

The change from baseline in carotid-femoral pulse wave velocity (PWV)
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

Secondary Outcome Measures

On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)
On central pulse pressure (PP) and augmentation index (AI)
On common carotid stiffness, intima-media thickness (IMT), and internal diameter

Full Information

First Posted
May 8, 2008
Last Updated
December 20, 2018
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00676845
Brief Title
Study to Determine if Olmesartan Medoxomil Has the Potential to Benefit the Cardiovascular System in Terms of Arterial Protection
Acronym
ArtStiff
Official Title
Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypertension
Keywords
Arterial stiffness, Vascular protection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
A 3-week placebo run-in period.
Arm Title
2
Arm Type
Experimental
Arm Description
Olmesartan medoxomil oral tablets, at lowest study dosage for 52-week double-blind treatment period
Arm Title
3
Arm Type
Experimental
Arm Description
Olmesartan medoxomil oral tablets at the lowest dosage for 4 weeks followed by a higher dosage for 48 weeks.
Arm Title
4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
dosage form: tablet; frequency: daily; duration: 3 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
dosage form: oral tablet; frequency: daily; duration: 52 weeks
Primary Outcome Measure Information:
Title
The change from baseline in carotid-femoral pulse wave velocity (PWV)
Time Frame
Up to 1 year of double-blind treatment
Title
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 Measure Information:
Title
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
Title
On central pulse pressure (PP) and augmentation index (AI)
Time Frame
Up to 1 year of double-blind treatment
Title
On common carotid stiffness, intima-media thickness (IMT), and internal diameter
Time Frame
Up to 1 year of double-blind treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Ghent
Country
Belgium
City
Nurnberg
Country
Germany
City
Monza
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
25001274
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs