HypertensionPhase 4NCT00242814
Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
A Phase 4 study testing Micardis, Amlodipine and Abdominal biopsy in people with Hypertension and Metabolic Syndrome X, run by Boehringer Ingelheim at 31 sites in France.
Trial summary
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypertension, Metabolic Syndrome X
- What is being tested?
- Micardis, Amlodipine and Abdominal biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 31 sitesFrance
- Study dates
- 3 Nov 2005to 29 Mar 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient written informed consent is signed prior to any trial specific procedures participation
- male patients > 18 years
- Mean seated SBP > 130mmHg and/or DBP > 85mmHg treated with antihypertensive drug(s)
- with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
- abdominal obesity > 102 cm at screening
- TG > 1.5 g/l
- HDL < 0.4 g/l
- Glycemia > 6 mmol/l
Who cannot join
- Patients with any of the following conditions will be excluded from trial:
- confirmed type 1 or 2 diabetic patients treated or not
- secondary hypertension
- Mean seated SBP>180 mmHg and/or DBP >110 mmHg at screening
- hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
- SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
Show all 24Show fewer
- serum creatinine ¿ 2.3 mg/dL (or 203 ¿mol/L)
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- patients post-renal transplant or with only one functioning kidney
- clinically relevant hypokalemia or hyperkalemia at visit 1
- uncorrected volume or sodium depletion at visit 1
- primary aldosteronism
- hereditary or known fructose intolerance
- biliary obstructive disorders
- patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-II receptor antagonists
- history of drug or alcohol dependency within the previous six months
- concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form
- symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
- unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
- stroke less than six months prior to informed consent
- sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
- known allergic hypersensitivity to any component of the formulations under investigation
- concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
502.486.3302A Cabinet Médical
Angers
502.486.3302B Cabinet Médical
Angers
502.486.3303A Boehringer Ingelheim Investigational Site
Angers
502.486.3305A Cabinet Médical
Angers
502.486.3323A Cabinet Médical
Angers
502.486.3323B Cabinet Médical
Angers
502.486.3324A Cabinet Médical
Angers
502.486.3324B Cabinet Médical
Angers
502.486.3325A Cabinet médical
Angers
502.486.3326A Cabinet Médical
Angers
502.486.3328A Cabinet Médical
Angers
502.486.3306A Cabinet Médical
Briollay
502.486.3307A Cabinet Médical
Chemillé-Melay
502.486.3319A Cabinet Médical
Cherbourg
502.486.3320A Cabinet Médical
Cherbourg
502.486.3320B Cabinet Médical
Cherbourg
502.486.3321A Cabinet Médical
Équeurdreville-Hainneville
502.486.3322A Boehringer Ingelheim Investigational Site
Évron
502.486.3312A Cabinet Médical
Feneu
502.486.3315A Cabinet Médical
La Rochelle
502.486.3308A Cabinet Médical
Montrevault
502.486.3316A Boehringer Ingelheim Investigational Site
Nieul-sur-Mer
502.486 3301A Boehringer Ingelheim Investigational Site
Paris
502.486.3301B Hôpital Pitié Salpêtrière
Paris
502.486.3310A Cabinet Médical
Saint-Pierre-Montlimart
502.486.3327A Cabinet Médical
Saumur
502.486.3309A Cabinet Médical Jean Charcot
Segré
502.486.3311A Cabinet Médical
Tiercé
502.486.3311B Cabinet Médical
Tiercé
502.486.3311C Cabinet Médical
Tiercé
502.486.3311D Cabinet Médical
Tiercé
About this study
Official title: A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.
An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).
- Conditions
- Hypertension, Metabolic Syndrome X
- Being tested
- Micardis, Amlodipine, Abdominal biopsy
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicardisDrug
AmlodipineDrug
Abdominal biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
Measured: At week 6
Secondary outcomes (1)
Comparison of serum level of TNF alpha, IL-6, leptine, hsCRP, TG, HDL and blood pressure control between two groups. Adipocyte differentiation in 30 patients (PPAR gamma stimulation) between two groups.
Measured: At week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study start3 Nov 2005
- Primary completion29 Mar 2007
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 Boehringer IngelheimThe 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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242814
- Sponsor's protocol ID
- 502.486
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2005
- Last updated
- 8 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00242814
- Acronym / sponsor ID
- 502.486
- Conditions
- Hypertension, Metabolic Syndrome X
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2005 (actual)
- Primary completion
- 29 Mar 2007 (actual)
- First posted
- 21 Oct 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.
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.
An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient written informed consent is signed prior to any trial specific procedures participation
- male patients > 18 years
- Mean seated SBP > 130mmHg and/or DBP > 85mmHg treated with antihypertensive drug(s)
- with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
- abdominal obesity > 102 cm at screening
Key exclusion criteria (24 listed)
- confirmed type 1 or 2 diabetic patients treated or not
- secondary hypertension
- Mean seated SBP>180 mmHg and/or DBP >110 mmHg at screening
- hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
- SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
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 |
|---|---|---|
| Micardis | Drug | – |
| Amlodipine | Drug | – |
| Abdominal biopsy | Procedure or surgery | – |
Primary outcome
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
Time frame: At week 6
1 secondary outcome
Comparison of serum level of TNF alpha, IL-6, leptine, hsCRP, TG, HDL and blood pressure control between two groups. Adipocyte differentiation in 30 patients (PPAR gamma stimulation) between two groups.
Time frame: At week 6
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 8 Dec 2023.
- Related InfoLink provided by the sponsor.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
31 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 Micardis, Amlodipine and Abdominal biopsy in people with Hypertension and Metabolic Syndrome X, run by Boehringer Ingelheim at 31 sites in France.
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 8 inclusion and 24 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. 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?
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups. (time frame: At week 6). 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 8 Dec 2023.