Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telmisartan; Telmisartan; Hydrochlorothiazide
Intervention description: Telmisartan 80mg; Telmisartan 80mg; Hydrochlorothiazide25mg
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 894.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to demonstrate that the fixed-dose combination of
      T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood
      Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3
      hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).
    

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 grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100
             mmHg at randomization

          4. Ability to stop any current antihypertensive therapy without unacceptable risk to the
             patient (Investigator's discretion)

        Exclusion criteria:

          1. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent)
             who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are
             of childbearing potential and are NOT practicing acceptable methods of birth control,
             or do NOT plan to continue practicing an acceptable method throughout the trial. The
             only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral
             contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal
             birth control should have been in use for at least three months before the study and
             continue at least until the next menstrual period after completing the study.

          2. Night shift workers who routinely sleep during the daytime and whose work hours
             include midnight to 4:00 a.m.

          3. Known or suspected secondary hypertension (e.g., renal artery stenosis
             orphaeochromocytoma)

          4. Mean in-clinic seated cuff SBP>= 200 mmHg and/or DBP >=120 mmHg

          5. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine
             >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of <30 ml/min and/or
             clinical markers of severe renal impairment.

          6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,
             post-renal transplant patients or patients with only one kidney

          7. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may
             be rechecked for suspected error in result)

          8. Uncorrected sodium or volume depletion

          9. Primary aldosteronism.

         10. Hereditary fructose intolerance

         11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency

         12. Congestive heart failure New York Heart Association functional class Congestive Heart
             Failure III-IV (Refer to Appendix 10.3)

         13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months,
             myocardial infarction, cardiac surgery, percutaneous transluminal coronary
             angioplasty, unstable angina or coronary artery bypass graft within the past 3 months
             prior to start of run in period)

         14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or
             other clinically relevant cardiac arrhythmias as determined by the Investigator

         15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease,
             aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

         16. Patients whose diabetes has not been stable and controlled for at least the past 3
             months as defined by an Glycosylated Hemoglobin >=10%

         17. Patients who have previously experienced symptoms characteristic of angioedema during
             treatment with ACE inhibitors or angiotensin-II receptor antagonists

         18. History of drug or alcohol dependency within 6 months prior to signing the informed
             consent form

         19. Concomitant administration of any medications known to affect blood pressure, except
             medications allowed by the protocol

         20. Any investigational drug therapy within 1 month of signing the informed consent

         21. Known hypersensitivity to any component of the trial drugs (telmisartan,
             hydrochlorothiazide, or placebo)

         22. History of non-compliance or inability to comply with prescribed medications or
             protocol procedures (less than 80% or more than 120%, especially during run-in)

         23. 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