The primary objective of this study is to evaluate the blood pressure control rate after 12 weeks of treatment with telmisartan/amlodipine FDC in patients who were previously not controlled on RAAS blocking mono-therapy (ARBs, ACEi, DRI).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for this trial is the percentage of patients achieving
blood pressure control (defined as SBP<140 mmHg and DBP<90 mmHg or SBP<130 mmHg
and DBP<80 mmHg in patients with diabetes or renal impairment) after 12 weeks
of treatment, determined by in-clinic BP measurements. Renal impairment is
defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine
>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between
30-60 ml/min.
Secondary outcome
Key secondary endpoints
• Percentage of patients achieving BP control (SBP<140 mmHg and DPB<90 mmHg)
using in-clinic BP at weeks 4 and 8.
Other secondary endpoints
• Percentage of patients achieving BP control using HBPM (SBP<135 mmHg and
DPB<85 mmHg) at week 12.
• Change from baseline in the in-clinic measured mean pulse pressure and mean
blood pressure after 4, 8 and 12 weeks.
• Response variables after 4, 8, and 12 weeks of treatment for in-clinic
measurements (systolic and diastolic):
• Percentage of patient in BP categories after 4, 8 and 12 weeks.
• Response variables after 4, 8, and 12 weeks of treatment for home measured BP
(HBPM) (systolic and diastolic):
• Proportion of patients requiring up titration to T80/A10 to achieve BP
control.
Safety endpoints
• Adverse events (AE) including incidence of peripheral oedema
• Changes from baseline in vital signs (pulse rate)
Background summary
Based on the continuous relationship between high BP and cardiovascular
morbidity and mortality JNC VII and the European Society of Hypertension have
emphasized the need for an effective treatment of hypertension. The respective
guidelines therefore recommend a target BP of <140/90 mmHg, but an even lower
target of <130/80 mmHg for those patients with co-morbidities such as diabetes
and chronic kidney disease. The ability of any agent used alone to achieve
target blood pressure values (140/90 mmHg) does not exceed 20-30% of the
overall hypertensive population except in subjects with grade 1 hypertension.
Hence, there is a need for effective antihypertensive combination therapy in
the majority of patients.
Study objective
The primary objective of this study is to evaluate the blood pressure control
rate after 12 weeks of treatment with telmisartan/amlodipine FDC in patients
who were previously not controlled on RAAS blocking mono-therapy (ARBs, ACEi,
DRI).
Study design
This is a prospective, single-arm, open-label, uncontrolled, multi-centre,
International trial to demonstrate the efficacy of the FDC of telmisartan plus
amlodipine in patients with hypertension not controlled on antihypertensive
mono-therapy with RAAS-inhibitors such as ARB, ACEi and DRI.
Intervention
After screening if the patient meets the inclusion criteria, the patient will
be switched from his or her prior antihypertensive treatment to the fixed dose
combination telmisartan/amlodipin 80/5 mmHg and will be uptitrated to
telmisartan/amlodipin 80/10 mg if the patient has still un uncontroled blood
pressure.
Study burden and risks
Patients whose BP is not adequately controlled by a single agent, can benefit
from treatment with a combination of two antihypertensive agents with different
mechanisms of action. Both components of the FDCs investigated in this trial
(i.e., telmisartan and amlodipine) are currently approved and marketed for the
treatment of essential hypertension in many countries throughout the world. It
can be considered established clinical practice to treat hypertensive patients
with combination of the single components of both drugs. Furthermore, the FDC
of telmisartan and amlodipine is approved and marketed in the US, and has been
submitted for approval to the European and Japanese health authorities.
Comeniusstraat 6
1817 MS Alkmaar
NL
Comeniusstraat 6
1817 MS Alkmaar
NL
Listed location countries
Age
Inclusion criteria
1.Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
2.Age 18 years or older
3.Patients with uncontrolled hypertension as defined SBP >=140 mmHg and SBP>=130 mmHg in patients with diabetes or renal impairment or DBP >=90 mmHg and DBP>=80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (ACE inhibition, ARB and Renin-inhibitors) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
Exclusion criteria
1.Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
2.Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
3.Mean in-clinic seated cuff SBP >=180 mmHg and SBP >=160 mmHg in patients with diabetes or renal impairment or DBP >=110 mmHg and DBP >=100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
4.Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 *mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
5.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
6.Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L).
7.Uncorrected sodium or volume depletion.
8.Primary aldosteronism.
9.Hereditary fructose intolerance.
10.Congestive heart failure NYHA functional class CHF III-IV (Refer to Appendix 10.1).
11.Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
12.Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x ASAT/ALAT values). (Refer to Appendix 10.3)
13.Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
14.History of drug or alcohol dependency within six months prior to signing the informed consent form.
15.Any investigational drug therapy within one month of signing the informed consent.
16.Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
17.History of non-compliance or inability to comply with prescribed medications or protocol procedures.
18.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.
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 | EUCTR2009-017336-40-NL |
| CCMO | NL31153.075.10 |
| Other | nog niet bekend |