TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over encapsulated tablets or telmisartan 80 mg tablets as first line therapy in patients with severe HyperTeNsion: a Phase III, 8-week, randomised, double-blind, double-dummy, forced-titration comparison [TEAMSTA severe HTN] - TEAMSTA Severe HTN

INTERVENTION: Product Name: telmisartan/amlodipine (80mg/10mg) fixed‐dose combination Product Code: T80/A10 Pharmaceutical Form: Tablet INN or Proposed INN: telmisartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ INN or Proposed INN: amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Norvasc Product Name: Norvasc Pharmaceutical Form: Capsule* INN or Proposed INN: amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: telmisartan/amlodipine (80mg/5mg) fixed‐dose combination Product Code: T80/A5 Pharmaceutical Form: Tablet INN or Proposed INN: telmisartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ INN or Proposed INN: amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Micardis Product Name: Micardis Product Code: T80 Pharmaceutical Form: Tablet INN or Proposed INN: telmisartan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Severe Hypertension ; MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension PRIMARY OUTCOME: Main Objective: The primary objective of this trial is to demonstrate that following eight weeks of treatment the fixed‐dose combination (FDC) of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing seated trough cuff systolic blood pressure (SBP) compared to both of the respective monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both monotherapies. Primary end point(s): Primary endpoint:; •Change from baseline in mean seated trough cuff systolic blood pressure (SBP) following eight weeks of treatment; Secondary Objective: Key secondary endpoints:; •Change from baseline in mean seated trough cuff SBP following one, two, four and six weeks of treatment; INCLUSION CRITERIA: All of the following inclusion criteria must be met in male and female patients. 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 severe hypertension as defined SBP =180 mmHg and DBP =95 mmHg 4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator’s discretion) 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