HypertensionPhase 3METATELNCT00560430
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
A Phase 3 study testing telmisartan in people with Hypertension and Metabolic Syndrome, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Hypertension, Metabolic Syndrome, Hypertriglyceridemia
- What is being tested?
- telmisartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2007to Oct 2009
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
- Triglycerides 150-400 mg/dl
- Normal stress test
- Normal carotid ultrasound
- Normal fundoscopy
Who cannot join
- Diabetes mellitus
- Secondary cause for insulin resistance
- LDL-cholesterol >190 mg/dl
- Atherosclerotic disease
- Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic)
- Regular alcohol consumption (>30 g/day)
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- Contraindication against telmisartan
- Antihypertensive medications
- Lipid lowering therapy
- Malignancy
- Pregnancy or Lactation
- Women without adequate contraception
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Center for Cardiovascular Research, University Berlin
Berlin, 10115
Med. Dept. 2, University Munich
Munich, 81377
About this study
A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.
- Conditions
- Hypertension, Metabolic Syndrome, Hypertriglyceridemia
- Being tested
- telmisartan, placebo
- Medical subject headings
- Hypertension, Metabolic Syndrome, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
80 mg per day, orally, weeks 1-14
telmisartanDrug
80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
placeboDrug
placebo; orally weeks 1-14
| Study group | Role | What they receive |
|---|---|---|
| T1 | Active comparator | Telmisartan 80 mg/d Receives: Drug: telmisartan |
| T2 | Active comparator | Telmisartan 160 mg/d Receives: Drug: telmisartan |
| P | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in IL-6
Measured: 14 weeks
Secondary outcomes (4)
change in fasting lipids;
Measured: 14 weeks
change in postprandial lipid metabolism
Measured: 14 weeks
change in inflammatory parameters
Measured: 14 weeks
change in glucose metabolism
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionOct 2009
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Klaus G Parhofer, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560430
- Sponsor's protocol ID
- KPUK0106
- Other IDs
- EudraCT 2006-003567-31
- Acronym
- METATEL
- Status last verified
- May 2008
- First submitted
- 16 Nov 2007
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00560430
- Acronym / sponsor ID
- METATEL / KPUK0106
- Conditions
- Hypertension, Metabolic Syndrome, Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2007 (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.
A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T1 | Active comparator | Drug: telmisartanTelmisartan 80 mg/d |
| T2 | Active comparator | Drug: telmisartanTelmisartan 160 mg/d |
| P | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
- Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
- Triglycerides 150-400 mg/dl
- Normal stress test
- Normal carotid ultrasound
Key exclusion criteria (12 listed)
- Diabetes mellitus
- Secondary cause for insulin resistance
- LDL-cholesterol >190 mg/dl
- Atherosclerotic disease
- Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic)
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 |
|---|---|---|
| telmisartan80 mg per day, orally, weeks 1-14 | Drug | T1 |
| telmisartan80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14 | Drug | T2 |
| placeboplacebo; orally weeks 1-14 | Drug | P |
Primary outcome
change in IL-6
Time frame: 14 weeks
4 secondary outcomes
change in fasting lipids;
Time frame: 14 weeks
change in postprandial lipid metabolism
Time frame: 14 weeks
change in inflammatory parameters
Time frame: 14 weeks
change in glucose metabolism
Time frame: 14 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 Jul 2010.
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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.
Klaus G Parhofer, MD principal investigator
Ludwig-Maximilians - University of Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telmisartan in people with Hypertension and Metabolic Syndrome, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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 12 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
change in IL-6 (time frame: 14 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 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.