Telmisartan, Amlodipine and Flow Mediated Dilation

NCT01180205 | Unknown Phase 4 DMC

• 1 other identifier: 2009-017010-68
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension

Keywords

FMD; hypertension; Telmisartan; Amlodipine

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline

• 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.

  after 26 weeks

Secondary Outcomes (4)

• Echogenicity

  baseline

• arterial stiffness

  baseline

• arterial stiffness

  after 26 weeks

• Echogenicity

  after 26 weeks

Study Arms (2)

T/A

ACTIVE COMPARATOR

Telmisartan + Amlopidpine

Drug: Telmisartan; Drug: Amlodipine

O/HCT

ACTIVE COMPARATOR

Olmesartan + Hydrochlorothiazide

Drug: Olmesartan medoxomil; Drug: Hydrochlorothiazide

Interventions

Telmisartan DRUG

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

Also known as: MICARDIS® (Telmisartan)

T/A

Amlodipine DRUG

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

Also known as: Norvasc

T/A

Olmesartan medoxomil DRUG

Olmesartan 40 mg po for 26 weeks

Also known as: Olmetec

O/HCT

Hydrochlorothiazide DRUG

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

O/HCT

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Amlodipine; Olmesartan Medoxomil; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Officials

• Stefan Blankenberg, Prof.Dr.med.

  Universitätsmedizin Mainz, II.Medizinische Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 12, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 12, 2011

Record last verified: 2010-04

Locations

DE (1)