Metabolic SyndromePhase 3VAMOSNCT00891267

Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

A Phase 3 study testing Olmesartan medoxomil tablets low dose, Olmesartan medoxomil tablets high dose and Amlodipine in people with Metabolic Syndrome and Hypertension, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolic Syndrome, Hypertension
What is being tested?: Olmesartan medoxomil tablets low dose, Olmesartan medoxomil tablets high dose and Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGermany
Study dates: Oct 2008to May 2011
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
Blood pressure greater than or equal to 130/85 mmHg AND
hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women
fasting blood glucose greater than or equal to 110mg/dL

Who cannot join

Insulin depended diabetes or type-1 diabetes
Severe or resistant hypertension
Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Any acute or chronic inflammatory disease
Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start
Pregnant or lactating female patients of childbearing potential (prerequisite: adequate contraception);
Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the trial drug(s)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Erlangen

Other trials in Germany

About this study

Official title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome

The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.

Conditions: Metabolic Syndrome, Hypertension
Being tested: Olmesartan medoxomil tablets low dose, Olmesartan medoxomil tablets high dose, Amlodipine
Keywords: Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension
Medical subject headings: Metabolic Syndrome, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olmesartan medoxomil tablets low doseDrug
Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Olmesartan medoxomil tablets high doseDrug
Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks
AmlodipineDrug
Amlodipine tablets taken once daily for 6 weeks

Study groups in NCT00891267
Study group	Role	What they receive
Olmesartan medoxomil low dose	Experimental	Olmesartan medoxomil tablets low dose, taken once daily for 6 weeks Receives: Drug: Olmesartan medoxomil tablets low dose
Olmesartan medoxomil tablets high dose	Experimental	Olmesartan medoxomil tablets high dose, taken once daily for 6 weeks Receives: Drug: Olmesartan medoxomil tablets high dose
Amlodipine	Active comparator	Amlodipine taken once daily for 6 weeks Receives: Drug: Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
Measured: 6 weeks for each treatment

Secondary outcomes (1)

To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM)
Measured: 6 weeks for each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008May 2011

First posted1 May 2009 (estimated)
Study startOct 2008
Primary completionApr 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00891267
Sponsor's protocol ID: DSE-866/46
Other IDs: 2007-003130-41 EudraCT number
Acronym: VAMOS
Status last verified: May 2011
First submitted: 29 Apr 2009
Last updated: 24 Dec 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Olmesartan Medoxomil on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
ClinicalTrials.gov ID: NCT00891267
Acronym / sponsor ID: VAMOS / DSE-866/46
Conditions: Metabolic Syndrome, Hypertension
Keywords: Inflammatory markers, Vascular protection, OM Effect, Metabolic syndrome, Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (estimated)
Lead sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Apr 2011 (actual)
Study completion: May 2011 (actual)
First posted: 1 May 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to study the effect of two doses of olmesartan medoxomil and amlodipine on vascular markers in hypertensive patients with metabolic syndrome.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Olmesartan medoxomil low dose	Experimental	Drug: Olmesartan medoxomil tablets low doseOlmesartan medoxomil tablets low dose, taken once daily for 6 weeks
Olmesartan medoxomil tablets high dose	Experimental	Drug: Olmesartan medoxomil tablets high doseOlmesartan medoxomil tablets high dose, taken once daily for 6 weeks
Amlodipine	Active comparator	Drug: AmlodipineAmlodipine taken once daily for 6 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male and female Europeans at the age of 18 years or above with hypertension, metabolic syndrome, and modest inflammation
Blood pressure greater than or equal to 130/85 mmHg AND
hs-CRP greater than or equal to 1.0 and less than 10.0 mg/dL AND at least two (2) of the following traits of the metabolic syndrome (ATP III criteria):
abdominal obesity: waist circumference greater than 102 cm for men and 88 cm for women;
triglyceride level greater than or equal to 150 mg/dL; HDL less than 40 mg/dL for men and less than 50 mg/dL for women

Key exclusion criteria (7 listed)

Insulin depended diabetes or type-1 diabetes
Severe or resistant hypertension
Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
Any acute or chronic inflammatory disease
Constant use of lipid-lowering agents (eg statins, fibrates) for less than 3 months before study start

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olmesartan medoxomil tablets low doseOlmesartan medoxomil tablets low dose, taken once daily for 6 weeks	Drug	Olmesartan medoxomil low dose
Olmesartan medoxomil tablets high doseOlmesartan medoxomil tablets high dose, taken once daily for 6 weeks	Drug	Olmesartan medoxomil tablets high dose
AmlodipineAmlodipine tablets taken once daily for 6 weeks	Drug	Amlodipine

Primary outcome

To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP
Time frame: 6 weeks for each treatment

1 secondary outcome

To evaluate the additional antihypertensive efficacy in blood pressure (BP) lowering, assessed by conventional BP measurement and 24-h ambulatory BP measurement (24-h ABPM)
Time frame: 6 weeks for each treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
Individual participant dataSharing planned: Yes. 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/

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
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Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the anti-inflammatory effect of Olmesartan (OM) higher dose compared to Olmesartan (OM) lower dose and amlodipine (AML) on the change in levels of the inflammatory marker hs-CRP (time frame: 6 weeks for each treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.