Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000125022
Ethics application status
Approved
Date submitted
4/02/2010
Date registered
8/02/2010
Date last updated
8/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Telmisartan on Arterial Stiffness Assessed by the Cardio-ankle Vascular Index in Hypertensive Patients
Scientific title
Effects of Telmisartan on Arterial Stiffness Assessed by the Cardio-ankle Vascular Index in Hypertensive Patients
Secondary ID [1] 1379 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 256750 0
arterial stiffness 256751 0
Condition category
Condition code
Cardiovascular 256905 256905 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Patients treated with telmisartan-based therapy were first treated with 20mg/day of telmisartan for 4 weeks. If after this time the target BP was not attained it was then subsequently increased up to a maximum dose of 80 mg/day until the target BP was attained. Additional antihypertensive agents other than renin-angiotensin system (RAS) inhibitors were added unless the blood pressure (BP) fell below the target BP.
b) the duration is 1 year.
c) the mode of administration is oral capsule.
Intervention code [1] 255967 0
Treatment: Drugs
Comparator / control treatment
Patients treated with calcium channel blockers (CCB)-based therapy (control group) were first treated with 20 mg/day of nifedipine, 2.5 mg/day of amlodipine, 5 mg/day of cilnidipine, or 2 mg/day of benidipine, and the doses of the CCBs were subsequently increased until the target BP was attained (up to 60 mg/day of nifedipine, 10 mg/day of amlodipine, 20 mg/day of cilnidipine, and 8 mg/day of benidipine). If the target BP was not achieved, additional antihypertensive medications other than telmisartan were added.
b) the duration is 1 year.
c) the mode of administration is oral capsule.
Control group
Active

Outcomes
Primary outcome [1] 257776 0
cardio-ankle vascular index (arterial stiffness)
Timepoint [1] 257776 0
1 year following randomisation
Primary outcome [2] 257777 0
the augmentation index (arterial stiffness)
Timepoint [2] 257777 0
1 year following randomisation
Primary outcome [3] 257778 0
the maximum of the carotid intima-media thickness (doppler ultrasound)
Timepoint [3] 257778 0
1 year following randomisation
Primary outcome [4] 257779 0
urinary albumin excretion
Timepoint [4] 257779 0
1 year following randomisation
Primary outcome [5] 257780 0
brain natriuretic peptide (blood analysis)
Timepoint [5] 257780 0
1 year following randomisation
Secondary outcome [1] 263180 0
blood pressure (automatic sphygmomanometer)
Timepoint [1] 263180 0
1 year following randomisation

Eligibility
Key inclusion criteria
hypertensive patients with arterial stiffness and untreated hypertension or uncontrollable hypertension treated with medications other than renin-angiotensin system (RAS) inhibitors
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with already taking RAS inhibitors

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2465 0
Japan
State/province [1] 2465 0

Funding & Sponsors
Funding source category [1] 256466 0
University
Name [1] 256466 0
Keio University School of Medicine
Country [1] 256466 0
Japan
Primary sponsor type
University
Name
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, 160-8582
Country
Japan
Secondary sponsor category [1] 255775 0
Hospital
Name [1] 255775 0
Keio University Hospital
Address [1] 255775 0
35 Shinanomachi, Shinjuku, Tokyo, 160-8582
Country [1] 255775 0
Japan

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Arterial stiffness is an independent prognostic predictor of cardiovascular morbidity and mortality. This study was conducted to determine the effect of telmisartan on the cardio-ankle vascular index (CAVI), a novel blood pressure (BP)-independent marker for arterial stiffness in hypertensive patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30804 0
Address 30804 0
Country 30804 0
Phone 30804 0
Fax 30804 0
Email 30804 0
Contact person for public queries
Name 14051 0
Atsuhiro Ichihara
Address 14051 0
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
Country 14051 0
Japan
Phone 14051 0
+81-3-5363-3796
Fax 14051 0
Email 14051 0
[email protected]
Contact person for scientific queries
Name 4979 0
Atsuhiro Ichihara
Address 4979 0
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
Country 4979 0
Japan
Phone 4979 0
+81-3-5363-3796
Fax 4979 0
Email 4979 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.