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HypertensionPhase 4TEAMSTAprotectNCT01180205

Telmisartan, Amlodipine and Flow Mediated Dilation

A Phase 4 study testing Telmisartan, Amlodipine and Olmesartan medoxomil in people with Hypertension, run by Johannes Gutenberg University Mainz at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal BP in both arms; target BP <140/90 mmHg (<130/80… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Hypertension
What is being tested?
Telmisartan, Amlodipine and Olmesartan medoxomil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
1 siteGermany
Study dates
Aug 2010to Oct 2011
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation.
  • Age 35 and older.
  • Male and female, treated and treatment-naive patients with uncontrolled hypertension (defined as 20/10 mmHg above target BP of <140/90 mmHg [<130/80 mmHg for renally impaired and/ or diabetics patients])
  • Male and female treated patients with controlled hypertension (defined as target BP < 140/90 mmHg [ < 130/80 mmHg for renally impaired and/ or diabetics patients])
  • > 3 cardiovascular risk factors CVRFs and/or metabolic syndrome and/or diabetes mellitus and/or end organ damage

Who cannot join

  • Pretreatment with Telmisartan within the last 3 months.
  • Pretreatment with Amlodipine, Diuretics and AT1Blocker/ACEInhibitor within the last 3 months
  • Myocardial infarction within last 6 months.
  • Previous stroke or hemodynamically relevant stenosis of carotic arteria (>70%).
  • Previous cardial or peripheral bypass surgery within last 6 months.
  • PAD stadium III - IV n.F.
Show all 41Show fewer
  • Chronic heart failure NYHA III- IV.
  • Unstable angina.
  • Known intolerance to angiotensin receptor blockers, diuretics or dihydropyridine calcium channel blocker.
  • Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
  • are not surgically sterile; or
  • are nursing, or
  • are pregnant, or
  • are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial.
  • The only acceptable methods of birth control are:
  • Intra-Uterine Device (IUD)
  • Oral
  • implantable or injectable contraceptives
  • Estrogen patch
  • Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study
  • Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  • Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
  • Mean in-clinic seated cuff SBP ≥180 mmHg and/or DBP ≥110 mmHg
  • Renal dysfunction as defined by the following laboratory parameters:
  • Serum creatinine >3.0 mg/dL (or >265 μmol/L) and/or known estimated creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
  • Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
  • Clinically relevant hypokalemia or hyperkalemia (i.e., <3.0 or >5.5 mEq/L, may be rechecked for suspected error in result)
  • Uncorrected sodium or volume depletion
  • Primary aldosteronism
  • Hereditary fructose intolerance
  • Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  • Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
  • Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  • Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥10%
  • Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  • History of drug or alcohol abuses within six months prior to signing the informed consent form
  • Concomitant administration of any medications known to affect BP, except medications allowed by the protocol
  • Any investigational drug therapy within one month of signing the informed consent
  • Known contraindication to any component of the trial drugs (telmisartan, amlodipine, olmesartan, hydrochlorothiazide)
  • History of non-compliance or inability to comply with prescribed medications or protocol procedures
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

About this study

Official title: A TElmisartan and AMlodipine STudy to Assess the Cardiovascular PROTECTive Effects as Measured by Endothelial Dysfunction in Hypertensive at Risk Patients Beyond Blood Pressure

To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by flow mediated dilation (FMD) in hypertensive at risk patients beyond bloodpressure BP (equal BP in both arms; target BP <140/90 mmHg (<130/80 mmHg for renally impaired and/ or diabetic patients). To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness and carotid atherosclerotic plaques.

Read the detailed description

This is a Phase IV, randomised, double-blind, forced- titration, active controlled, mono-center study to primarily compare the effects on endothelial function of the combination of telmisartan and amlodipine versus olmesartan and hydrochlorothiazide in hypertensive patients at risk beyond blood pressure. Additionally, key secondary endpoints for this trial are the changes in plaque and intima media complex echogenicity and the change in arterial stiffness after 26 weeks of treatment.

576 patients will be included in the study after a screening period of two weeks and then randomised in one of the two treatment groups. Pretreatment with ARBs, ACE-Inhibitors, amlodipine and diuretics will be stopped last day before visit 2. At visit 2 the treatment with either telmisartan and amlodipine or olmesartan and hydrochlorothiazide starts, so that no medication is stopped without having been replaced by the study medication. After two weeks treatment all patients will be up-titrated and having the maintenance dose for the following 24 weeks. The trial will be performed at one center in Germany with access to patients with hypertension. Patients will be recruited from the Department of Cardiology of the university Mainz. There will be a promotion flyer and an information booklet about the study for cardiologists practicising near Mainz, who like to sent their patient to the study center. Sponsor of the trial is the university Mainz.

Stefan Blankenberg, MD has been designated as Principal Investigator for this national, mono-center trial.

The study will be completed when the last patient had his last visit and the telephone follow - up two weeks later will be performed. This latest patient contact is defined as end of trial.

Conditions
Hypertension
Being tested
Telmisartan, Amlodipine, Olmesartan medoxomil, Hydrochlorothiazide
Keywords
FMD, hypertension, Telmisartan, Amlodipine
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelmisartanDrug

    Also called MICARDIS® (Telmisartan)

    Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)

  • AmlodipineDrug

    Also called Norvasc

    Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks

  • Olmesartan medoxomilDrug

    Also called Olmetec

    Olmesartan 40 mg po for 26 weeks

  • HydrochlorothiazideDrug

    HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks

Study groups in NCT01180205
Study groupRoleWhat they receive
T/AActive comparatorTelmisartan + Amlopidpine
Receives: Drug: Telmisartan; Drug: Amlodipine
O/HCTActive comparatorOlmesartan + Hydrochlorothiazide
Receives: Drug: Olmesartan medoxomil; Drug: Hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FMD flow mediated dilation

    The overall mean improvement following 26 weeks of treatment in FMD as measured by the change from Visit 2 for T80/A10 is equal to O40/H25.

    Measured: baseline

  2. FMD

    The overall mean improvement following 26 weeks of treatment in FMD as measured by the change from Visit 2 for T80/A10 is equal to O40/H25.

    Measured: after 26 weeks

Secondary outcomes (4)

  1. Echogenicity

    To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques

    Measured: baseline

  2. arterial stiffness

    To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness

    Measured: baseline

  3. arterial stiffness

    To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness

    Measured: after 26 weeks

  4. Echogenicity

    To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques

    Measured: after 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2011 (estimated)
  4. Study completionOct 2011 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
576 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01180205
Sponsor's protocol ID
2009-017010-68
Other IDs
2009
Acronym
TEAMSTAprotect
Status last verified
Apr 2010
First submitted
4 Aug 2010
Last updated
12 Jul 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan, Amlodipine and Olmesartan medoxomil in people with Hypertension, run by Johannes Gutenberg University Mainz at 1 site 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 5 inclusion and 41 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: status not confirmed, as of the sponsor's last update on 12 Jul 2011. 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 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. 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?

Results are not available in the source record.

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?

FMD flow mediated dilation (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01180205.

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 12 Jul 2011.

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