HypertensionPhase 4VIOSNCT00772499
Vascular Improvement With Olmesartan Medoxomil Study
A Phase 4 study of Hypertension, run by Daiichi Sankyo at 1 site in United States.
Trial summary
The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jul 2005
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18-75 years of age
- Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179
Who cannot join
- Secondary hypertension
- Renal disease
- Diabetes mellitus
- Serum creatinine >3.0 mg/dL
- Hemoglobin <10 mg/dL (males) or <9mg/dL (females)
- WBC count <2000 cells/mL
Show all 10Show fewer
- Platelet count <100,000 cells/mL
- Either ALT \& AST >2.5 x upper limit of normal
- BMI >35 kg/m2
- TIA or cerebrovascular attack within 3 months of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.
- Conditions
- Hypertension
- Being tested
- olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure, atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureDrug
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureDrug
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure Receives: Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure |
| 2 | Active comparator | Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure Receives: Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
Measured: 52 weeks
Secondary outcomes (14)
Results of vascular function tests
Measured: 12 weeks
Results of vascular function tests
Measured: 28 weeks
Results of vascular function tests
Measured: 52 weeks
Measurement of serum lipid and markers of atherosclerosis
Measured: 12 weeks
Measurement of serum lipid and markers of atherosclerosis
Measured: 28 weeks
Measurement of serum lipid and markers of atherosclerosis
Measured: 52 weeks
Retinal arteriole measurements
Measured: 52 weeks
Calculation of insulin sensitivity measurement
Measured: 12 Weeks
Calculation of insulin sensitivity measurement
Measured: 28 weeks
Calculation of insulin sensitivity measurement
Measured: 52 weeks
24 hour urine creatinine and thromboxane B2 measurements
Measured: 12 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Measured: 12 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Measured: 28 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startNov 2002
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772499
- Sponsor's protocol ID
- 866-432
- Acronym
- VIOS
- Status last verified
- Oct 2008
- First submitted
- 13 Oct 2008
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Improvement With Olmesartan Medoxomil Study
- ClinicalTrials.gov ID
- NCT00772499
- Acronym / sponsor ID
- VIOS / 866-432
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 15 Oct 2008 (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 compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureolmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure |
| 2 | Active comparator | Drug: atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureAtenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- 18-75 years of age
- Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179
Key exclusion criteria (10 listed)
- Secondary hypertension
- Renal disease
- Diabetes mellitus
- Serum creatinine >3.0 mg/dL
- Hemoglobin <10 mg/dL (males) or <9mg/dL (females)
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 + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureTablets and capsules for oral administration once or twice daily for up to 52 weeks | Drug | 1 |
| atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressureTablets and capsules for oral administration once or twice daily for up to 52 weeks | Drug | 2 |
Primary outcome
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy
Time frame: 52 weeks
14 secondary outcomes
Results of vascular function tests
Time frame: 12 weeks
Results of vascular function tests
Time frame: 28 weeks
Results of vascular function tests
Time frame: 52 weeks
Measurement of serum lipid and markers of atherosclerosis
Time frame: 12 weeks
Measurement of serum lipid and markers of atherosclerosis
Time frame: 28 weeks
Measurement of serum lipid and markers of atherosclerosis
Time frame: 52 weeks
Retinal arteriole measurements
Time frame: 52 weeks
Calculation of insulin sensitivity measurement
Time frame: 12 Weeks
Calculation of insulin sensitivity measurement
Time frame: 28 weeks
Calculation of insulin sensitivity measurement
Time frame: 52 weeks
24 hour urine creatinine and thromboxane B2 measurements
Time frame: 12 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Time frame: 12 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Time frame: 28 weeks
Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio
Time frame: 52 weeks
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 15 Oct 2008.
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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?
A Phase 4 study of Hypertension, run by Daiichi Sankyo at 1 site in United States.
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 3 inclusion and 10 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 15 Oct 2008. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2008.