TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
Condition: Hypertension
MeSH terms: Hypertension
Intervention: telmisartan/amlodipine
Intervention description: start low dose and uptitrate to high dose on the basis of BP goal
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The general aim of this trial to determine the efficacy as measured by the percentage of
      patients reaching blood pressure goal at the end of the treatment period at 12 weeks.
      In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
    

Eligibility 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 (Angiotensin Converting Enzym
             inhibition, AII Receptor Blocker and Direct Renin Inhibitor) 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 Systolic BP >180 mmHg and SBP >160 mmHg in patients with
             diabetes or renal impairment or Diastolic BP >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 New York Heart Association functional class Congestive Heart
             Failure 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 transaminases 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.