NCT00676845

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2008

Typical duration for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 24, 2018

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

May 8, 2008

Last Update Submit

December 20, 2018

Conditions

Metabolic SyndromeHypertension

Keywords

Arterial stiffnessVascular protection

Outcome Measures

Primary Outcomes (2)

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

    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

    Up to 1 year of double-blind treatment

Secondary Outcomes (3)

  • On blood pressure (BP) lowering, assessed by conventional BP measurement and 24h ambulatory BP measurement (24h-ABPM)

    Up to 1 year of double-blind treatment

  • On central pulse pressure (PP) and augmentation index (AI)

    Up to 1 year of double-blind treatment

  • On common carotid stiffness, intima-media thickness (IMT), and internal diameter

    Up to 1 year of double-blind treatment

Study Arms (4)

1

PLACEBO COMPARATOR

A 3-week placebo run-in period.

Drug: placebo

2

EXPERIMENTAL

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

Drug: olmesartan medoxomil

3

EXPERIMENTAL

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

Drug: olmesartan medoxomil

4

EXPERIMENTAL

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

Interventions

olmesartan medoxomilDRUG

dosage form: oral tablet; frequency: daily; duration: 52 weeks

2
placeboDRUG

dosage form: tablet; frequency: daily; duration: 3 weeks

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Nuremberg, Germany

Location

Unknown Facility

Monza, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25001274DERIVED

MeSH Terms

Conditions

Metabolic SyndromeHypertension

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 24, 2018

Record last verified: 2012-04

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.
More information

Locations

DE(1)IT(1)BE(1)