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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-000874-19-NL |
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Date of registration:
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16/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase III, eight week randomised double-blind, double-dummy,
forced titration study to compare the fixed-dose combination tablet of
telmisartan 80 mg plus amlodipine 10 mg versus amlodipine 10 mg
over encapsulated capsules mono-therapy as first line therapy in
patients with type 2 diabetes mellitus and Stage I or II hypertension - TEAMSTAT2DM
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Scientific title:
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A Phase III, eight week randomised double-blind, double-dummy,
forced titration study to compare the fixed-dose combination tablet of
telmisartan 80 mg plus amlodipine 10 mg versus amlodipine 10 mg
over encapsulated capsules mono-therapy as first line therapy in
patients with type 2 diabetes mellitus and Stage I or II hypertension - TEAMSTAT2DM |
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Date of first enrolment:
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19/11/2008 |
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Target sample size:
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400 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000874-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: double-dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Baseline mean seated systolic blood pressure >150 mmHg; diagnosis of type 2 diabetes mellitus; age = >18; ability to stop current antihypertensive therapy without unacceptable risk to the patient and ability to provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Pre-menopausal women who are not pregnant, nursing, surgically sterile or practicing approved birth control; night shift workers; mean seated systolic =>180 and/or diastolic >=120 mmHg; type 1 diabetes mellitus; renal dysfunttion defined by laboratory parameters; functional class III-IV CHF; sensitivity to study drugs; concomitant medication known to affect blood pressure and unstable diabetes defined by HbA1c >10%
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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type 2 diabetes and mild to moderate hypertension
MedDRA version: 9.1
Level: LLT
Classification code 10020772
Term: Hypertension
MedDRA version: 9.1
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
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Intervention(s)
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Product Name: telmisartan/amlodipine (80mg/10mg) fixed-dose combination
Product Code: T80/A10
Pharmaceutical Form: Tablet
INN or Proposed INN: telmisartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
INN or Proposed INN: amlodipine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Norvasc
Product Name: Norvasc
Pharmaceutical Form: Capsule*
INN or Proposed INN: amlodipine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: telmisartan/amlodipine (80mg/5mg) fixed-dose combination
Product Code: T80/A5
Pharmaceutical Form: Tablet
INN or Proposed INN: telmisartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
INN or Proposed INN: amlodipine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The change from baseline in the mean seated trough cuff systolic blood pressure after eight weeks of treatment.
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Main Objective: To demonstrate that the fixed-dose combination of telmisartan 80 mg plus amlodipine 10 mg is superior as first line therapy in reducing mean seated trough cuff systolic blood presure compared to the monotherapy of amlodipine 10 mg in patients with type 2 diabetes and Stage I or II hypertension.
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Secondary Objective: To assess changes from baseline in diastolic blood pressure and blood pressure control variables. As well, safety will be assessed.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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