Telmisartan, Amlodipine and Flow Mediated Dilation (TEAMSTAprotect)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Johannes Gutenberg University Mainz.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01180205
First received: August 4, 2010
Last updated: July 11, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Telmisartan
Drug: Amlodipine
Drug: Olmesartan medoxomil
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • FMD flow mediated dilation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • FMD [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Echogenicity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques

  • arterial stiffness [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness

  • arterial stiffness [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
    To investigate the effects of T and A vs O and HCTZ in reducing arterial stiffness

  • Echogenicity [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
    To investigate the effects of T and A vs O and HCTZ on grayscale median of carotid atherosclerotic plaques


Estimated Enrollment: 576
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: T/A
Telmisartan + Amlopidpine
Drug: Telmisartan
Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
Other Name: MICARDIS® (Telmisartan)
Drug: Amlodipine
Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks
Other Name: Norvasc
Active Comparator: O/HCT
Olmesartan + Hydrochlorothiazide
Drug: Olmesartan medoxomil
Olmesartan 40 mg po for 26 weeks
Other Name: Olmetec
Drug: Hydrochlorothiazide
HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Pretreatment with Telmisartan within the last 3 months.
  2. Pretreatment with Amlodipine, Diuretics and AT1Blocker/ACEInhibitor within the last 3 months
  3. Myocardial infarction within last 6 months.
  4. Previous stroke or hemodynamically relevant stenosis of carotic arteria (>70%).
  5. Previous cardial or peripheral bypass surgery within last 6 months.
  6. PAD stadium III - IV n.F.
  7. Chronic heart failure NYHA III- IV.
  8. Unstable angina.
  9. Known intolerance to angiotensin receptor blockers, diuretics or dihydropyridine calcium channel blocker.
  10. Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:

    1. are not surgically sterile; or
    2. are nursing, or
    3. are pregnant, or
    4. 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:

    5. Intra-Uterine Device (IUD)
    6. Oral
    7. implantable or injectable contraceptives
    8. Estrogen patch
    9. 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
  11. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  12. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
  13. Mean in-clinic seated cuff SBP ≥180 mmHg and/or DBP ≥110 mmHg
  14. Renal dysfunction as defined by the following laboratory parameters:
  15. 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.
  16. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
  17. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.0 or >5.5 mEq/L, may be rechecked for suspected error in result)
  18. Uncorrected sodium or volume depletion
  19. Primary aldosteronism
  20. Hereditary fructose intolerance
  21. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  22. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
  23. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  24. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥10%
  25. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  26. History of drug or alcohol abuses within six months prior to signing the informed consent form
  27. Concomitant administration of any medications known to affect BP, except medications allowed by the protocol
  28. Any investigational drug therapy within one month of signing the informed consent
  29. Known contraindication to any component of the trial drugs (telmisartan, amlodipine, olmesartan, hydrochlorothiazide)
  30. History of non-compliance or inability to comply with prescribed medications or protocol procedures
  31. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180205

Locations
Germany
Universitätsmedizin Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Stefan Blankenberg, Prof.Dr.med. Universitätsmedizin Mainz, II.Medizinische Klinik
  More Information

No publications provided

Responsible Party: Prof.Dr.med.S.Blankenberg, Departement for cardiology
ClinicalTrials.gov Identifier: NCT01180205     History of Changes
Other Study ID Numbers: 2009-017010-68
Study First Received: August 4, 2010
Last Updated: July 11, 2011
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
FMD
hypertension
Telmisartan
Amlodipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Olmesartan medoxomil
Olmesartan
Hydrochlorothiazide
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 28, 2014