Hypertension MedDRA version: 12.1 Level: LLT Classification code 10005757 Term: Blood pressure systolic abnormal MedDRA version: 12.1 Level: LLT Classification code 10005728 Term: Blood pressure abnormal MedDRA version: 12.1 Level: LLT Classification code 10005736 Term: Blood pressure diastolic abnormal
Conditions
Interventions
Trade Name: TWYNSTA
Product Name: telmisartan/amlodipine (80mg/5mg) fixed-dose combination
Product Code: T80/A5
Pharmaceutical Form: Tablet
INN or Proposed INN: amlodipine
CAS Number: 111470-99-6
Curr
Sponsors
Boehringer Ingelheim BV
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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). ;Secondary Objective: 1 Percentage of patients achieving BP control (SBP<140 mmHg and DPB<90 mmHg) using in-clinic BP at weeks 4 and 8. 2 Percentage of patients achieving BP control using HBPM (SBP<135 mmHg and DPB<85 mmHg) at week 12. 3 Change from baseline in the in-clinic measured mean pulse pressure and mean blood pressure after 4, 8 and 12 weeks. 4 Response variables after 4, 8, and 12 weeks of treatment for in-clinic measurements 5 Percentage of patient in BP categories after 4, 8 and 12 weeks. 6 Response variables after 4, 8, and 12 weeks of treatment for home measured BP (HBPM) 7 Proportion of patients requiring up titration to T80/A10 to achieve BP control. 8 safety endpoints (AE and change from baseline ;Primary end point(s): The primary endpoint for this trial is the percentage of patients achieving blood pressure control (defined as SBP<140 mmHg and DBP<90 mmHg) after 12 weeks of treatment, determined by in-clinic BP measurements. | — |
Countries
Germany, Italy, Netherlands
Outcome results
None listed