HypertensionPhase 4NCT00185094
A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to Insulin
A Phase 4 study testing Olmesartan medoxomil, Losartan potassium and Atenolol in people with Hypertension and Insulin Resistance, run by Daiichi Sankyo at 10 sites in United States.
Trial summary
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Olmesartan medoxomil, Losartan potassium and Atenolol
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2004to 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
- Patients between the ages of 18 and 75 years (inclusive)
- Willingness to undergo insulin clamp procedure twice
- Overweight or obese (BMI=25-39 kg/m2)
- Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure < 140 mmHg and diastolic blood pressure 90-99 mmHg
- If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
Who cannot join
- Systolic blood pressure > 179 mmHg
- Diastolic blood pressure > 99 mmHg or < 85 mmHg
- Diagnosis of diabetes mellitus
- History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
- Previous history of a cerebrovascular accident or a transient ischemic attack
- History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components
- Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data
- Laboratory abnormalities that could compromise subject safety
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Indianapolis, Indiana
Study site
Miami, Florida
Study site
Philadelphia, Pennsylvania
Study site
Rochester, Minnesota
Study site
San Antonio, Texas
Study site
San Diego, California
About this study
Official title: The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
- Conditions
- Hypertension, Insulin Resistance, Metabolic Syndrome
- Being tested
- Olmesartan medoxomil, Losartan potassium, Atenolol
- Medical subject headings
- Hypertension, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
Losartan potassiumDrug
AtenololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary outcomes (2)
-To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
-To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2004
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185094
- Sponsor's protocol ID
- 866-440
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 23 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
- ClinicalTrials.gov ID
- NCT00185094
- Acronym / sponsor ID
- 866-440
- Conditions
- Hypertension, Insulin Resistance, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Jul 2005
- First posted
- 16 Sep 2005 (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.
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between the ages of 18 and 75 years (inclusive)
- Willingness to undergo insulin clamp procedure twice
- Overweight or obese (BMI=25-39 kg/m2)
- Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure < 140 mmHg and diastolic blood pressure 90-99 mmHg
- If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
Key exclusion criteria (8 listed)
- Systolic blood pressure > 179 mmHg
- Diastolic blood pressure > 99 mmHg or < 85 mmHg
- Diagnosis of diabetes mellitus
- History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
- Previous history of a cerebrovascular accident or a transient ischemic attack
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 | Drug | – |
| Losartan potassium | Drug | – |
| Atenolol | Drug | – |
Primary outcome
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
2 secondary outcomes
-To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
-To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity
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 23 Dec 2005.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olmesartan medoxomil, Losartan potassium and Atenolol in people with Hypertension and Insulin Resistance, run by Daiichi Sankyo at 10 sites 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 5 inclusion and 8 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 23 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity. 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 23 Dec 2005.