ObesityPhase 4OBINCT00987662
Irbesartan Versus Amlodipine: The OBI Study
A Phase 4 study testing Irbesartan and Amlodipine in people with Obesity and Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Objective: 1. To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects 2. To study the drug specific effect in arterial stiffness 3. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Irbesartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Jan 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- All patients are going to give their informed consent to participate in the study.
- Stage I hypertension.
- BMI > 30.
Who cannot join
- Known oversensitiveness,
- Chronic renal disease (GFR < 50 ml/min) or ESRD,
- Heart or respiratory failure, OR
- Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study
Objective:
- To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
- To study the drug specific effect in arterial stiffness
- To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)
Read the detailed description
Study Objectives
- Primary:
- Reduction of 24h BP in obese hypertensives
- Reduction in arterial stiffness
- Secondary
- Drug specific effect on new onset of diabetes
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Study design
Study drugs: Irbesartan 300mg vs. amlodipine 10mg
Tx duration and follow-up: 12 months
Collected data:
- 24h SBP and DBP in time 0, 1, 12.
- Pulse wave velocity in time 0,1,12.
- Central obesity (total, visceral, abdominal fat) in time 0,1,12.
- Leptin/adiponectin in time 0,1,12.
- BMI, waist/hip ratio in time 0,1, 12.
- Glu, HbA1c, insulin in time 0, 1,12.
- K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula)
Number of centers: 1
- Conditions
- Obesity, Hypertension
- Being tested
- Irbesartan, Amlodipine
- Keywords
- irbesartan, amlodipine, obesity, ambulatory blood pressure monitoring, new onset diabetes
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg.
AmlodipineDrug
Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan | Active comparator | Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg. Receives: Drug: Irbesartan |
| Amplodipine | Active comparator | Treatment with amlodipine 10 mg for 4 weeks. If BP>135/85 mmHg add hydrochlorothiazide 12.5 mg Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 24h BP and arterial stiffness in obese hypertensives
Measured: 12
Secondary outcomes (2)
New onset of diabetes
Measured: 12
Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Vasilios Kotsis, Prof, Study chair, AUTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987662
- Sponsor's protocol ID
- AUTH170909
- Acronym
- OBI
- Status last verified
- Sep 2009
- First submitted
- 30 Sep 2009
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study
- ClinicalTrials.gov ID
- NCT00987662
- Acronym / sponsor ID
- OBI / AUTH170909
- Conditions
- Obesity, Hypertension
- Keywords
- irbesartan, amlodipine, obesity, ambulatory blood pressure monitoring, new onset diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Oct 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.
Objective:
- To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects
- To study the drug specific effect in arterial stiffness
- To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)
Detailed description
Study Objectives
- Primary:
- Reduction of 24h BP in obese hypertensives
- Reduction in arterial stiffness
- Secondary
- Drug specific effect on new onset of diabetes
- Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Study design
Study drugs: Irbesartan 300mg vs. amlodipine 10mg
Tx duration and follow-up: 12 months
Collected data:
- 24h SBP and DBP in time 0, 1, 12.
- Pulse wave velocity in time 0,1,12.
- Central obesity (total, visceral, abdominal fat) in time 0,1,12.
- Leptin/adiponectin in time 0,1,12.
- BMI, waist/hip ratio in time 0,1, 12.
- Glu, HbA1c, insulin in time 0, 1,12.
- K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula)
Number of centers: 1
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan | Active comparator | Drug: IrbesartanTreatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg. |
| Amplodipine | Active comparator | Drug: AmlodipineTreatment with amlodipine 10 mg for 4 weeks. If BP>135/85 mmHg add hydrochlorothiazide 12.5 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years.
- All patients are going to give their informed consent to participate in the study.
- Stage I hypertension.
- BMI > 30.
Key exclusion criteria (4 listed)
- Known oversensitiveness,
- Chronic renal disease (GFR < 50 ml/min) or ESRD,
- Heart or respiratory failure, OR
- Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or lactation.
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 |
|---|---|---|
| IrbesartanTreatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg. | Drug | Irbesartan |
| AmlodipineTreatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg | Drug | Amplodipine |
Primary outcome
Reduction of 24h BP and arterial stiffness in obese hypertensives
Time frame: 12
2 secondary outcomes
New onset of diabetes
Time frame: 12
Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio
Time frame: 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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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.
Vasilios Kotsis, Prof study chair
AUTH
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 testing Irbesartan and Amlodipine in people with Obesity and Hypertension, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 Feb 2014. 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 Greece. 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of 24h BP and arterial stiffness in obese hypertensives (time frame: 12). 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 11 Feb 2014.