This study investigates whether the fixed-dose combination of telmsartan 80 plus amlodipine 5 or 10 is superior as a first line treatment to amlodipine 5 or 10 mg monotherapy of lowering mean sitting systolisch blood pressure in patients with…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cardiovasculair, hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
the change from baseline in the mean seated trough cuff SBP following eight
weeks of treatment
Secondary outcome
Secundary endoints:
1. Key secundary endpoints
change from baseling in the mean seated trough cuff SBP following four and six
weeks of treatment (T80/A10 verus A10) and following one and two weeks of
treatment (T80/A5 versus A5)
2. Other secundary endpoints:
- change from baseling in mean seated trough cuff DBP after one, two, four, six
and eight weeks of treatment
- response variables after one, two, four, six and eight weeks of treatment
DBP control (mean seated DBP<80 mmHg)
BP control (mean seated SBP<130 mmHg and mean seated DBP<80 mmHg)
DBP response (mean seated DBP<80 mmHg or a reduction of >=10 mmHg)
SBP response (mean seated SBP<130 mmHg or a reduction of >=10 mmHg)
BP normal (optimal: SBP<120 mmHg and DBP<80 mmHg)
(normal: SBP>=120 mmHg and <130 mmHg and DBP>=80
mmHg and <85 mmHg)
(high normal: SBP>=130 mmHg and <140 mmHg and
DBP>=85 mmHg and <90 mmHg)
(high: SBP>=140 mmHg or DBP>=90 mmHg)
- change from baseline in urine albumin:creatinine ratio (UACR; measured in
spot urine) after eight weeks of treatment
Safety endpoints
- adverse events
- changes from baseline in pulse rate
- changes in laboratory parameters
- ECG changes
- incidence of peripheral oedema
- orthostatic changes in SBP and DBP (calculated for both SBP and DBP as the
mean seated BP at a particular visit substracted from the first standing BP at
the same visit)
Background summary
Title study
Telmisartan 80 mg plus amlodipine 10 mg fixed-dose combination tablet study
versus amlodipine 10 mg over-encapsulated tablets as first line therapy in
patients with type 2 diabetes mellitus and stage 1 or 2 hypertension: a phase
III, eight week, randomised, double-blind, double-dummy, forced titration
comparison.
New European guideline (European Society of Hypertension and Cardiology)
acknowledge the need for an aggresive treatment of hypertension. This is based
on the relation of hypertension and cardiovasculare morbidity and mortality.
Diabetes mellitus is a big and growing health problem. Hypertension occurs in
over half of these patients. Early treatment of hypertension in this patient
group can delay the occurence of complications and therefore improve prognosis.
Independantly hypertension and diabetes mellitus predispose to renal and
cardiovascular problems. When those diseases occur together they exacerbate the
risk of those complications. Therefore it is important in this
patientpopulation to have even more strict guidelines for hypertension: <130/80
mmHg to lower the complication risk.
Large studies have shown that the majority of patients won't achieve there
bloodpressure goal by treatment with one medicine. Adding a second therapy from
a different treatment group is an option when the bloodpressure goal is not
met. An alternative strategy is starting a fixed-dose combination or starting
treatment with two types of medicine from the start fo treatment. This study
tries to establish if this strategy is effective and safe.
Study objective
This study investigates whether the fixed-dose combination of telmsartan 80
plus amlodipine 5 or 10 is superior as a first line treatment to amlodipine 5
or 10 mg monotherapy of lowering mean sitting systolisch blood pressure in
patients with diabetes mellitus type 2 and stage 1 or 2 hyeprtension.
Effectiveness of telmisartan 80 plus amlodipine 10 mg (T80/A10) versus
amlodipine 10 mg (A10) is studied after 4,6 and 8 weeks of treatment as well as
the effectiveness of telmisartan 80 mg plus amlodipine 5 mg (T80/A5) versus
amlodipine 5 mg (A5) after 1 and 2 weeks of treatment.
Study design
This study compares the effectiveness and safety of 2 different treatment
strategies:
1. the fixed-dose combination of telmisartan 80 mg and amlodipine 5 mg after 2
weeks forced titrated to telmisartan 80 mg and amlodipine 10 mg, or
2. amlodipine 5 mg, after 2 weeks forced titrated to amlodipine 10 mg
The study lasts for about 8 to 9 weeks. During the study there are 8 visites
for the patient to the physician. The study starts with a screeningperiod of
maximal 7 days. This screeningperiod is used to check whether the patient is
eligible for participation in the study. After the screeningperiod the run-in
period. Every patient receives placebo treatment during 2 to 3 weeks to achieve
a washout of all stopped hypertensive medication.
If the systolisch bloodpressure after this run-in period is over 150 mmHg the
patient is randomised to one of both treatment groupw. After 1 and 2 weeks the
patient returns for bloodpressure measurmentens and the medication is forced
titrated. After 4, 6 and 8 weeks after randomisation bloodpressure measurements
will be repeated during the usage of the higher dose of medication.
During the last visit the physician will discuss the hypertension treatment of
the patient after the study.
Intervention
Patients take their studydrug once daily. After a placebo run-in period the
patients will be randomised to one of two treatment strategies:
1. fixed-dose combination of telmisartan 80 mg and amlodipine 5 mg, after 2
weeks forced titrated to telmisartan 80 mg and amlodipine 10 mg, or
2. amlodipine 5 mg, after 2 weeks forced titrated to amlodipine 10 mg.
Study burden and risks
One time physical examination
Two times ECG
Maximal three times laboratory (depending whether the patients gets randomised)
In females maximal three times a urine pregnancy test will be performed
(depending whether the patients gets randomised)
At every visit blood pressure will be measured sitting and at the end of the
treatment also standing one time.
Comeniusstraat 6
1817 MS Alkmaar
NL
Comeniusstraat 6
1817 MS Alkmaar
NL
Listed location countries
Age
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.
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%
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000874-19-NL |
| CCMO | NL23348.040.08 |
| Other | NTC-nummer nog niet bekend |