Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.
Brief Summary: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.


Options:
A: Inclusion Criteria:

* Patients who are above target LDL-C and BP who are eligible for treatment

Exclusion Criteria:

* High liver enzymes
B: Inclusion Criteria:

1. patients aged at least 18 years
2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

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
2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
3. discontinuation from the preceding trial because of any adverse event or any other reason
4. known or suspected secondary hypertension
5. mean seated Systolic Blood Pressure =\> 180 mmHg and/or mean seated Diastolic Blood Pressure =\> 120 mmHg at any visit
C: Inclusion Criteria:

* Adults (≥ 18 years)
* The participant is able to give informed consent.
* Established atherothrombotic cardiovascular disease (CVD) or high cardiovascular risk, of for individuals without established cardiovascular disease, a calculated 5 year CVD risk of 15% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations)
* The trial Investigator considers that each of the polypill components are indicated
* The trial Investigator is unsure as to whether a polypill-based strategy or usual care is better.

Exclusion Criteria:

* Contraindication to any of the components of the polypill (e.g. known intolerance to aspirin, statins, or ACE inhibitors,pregnancy or likely to become pregnant during the treatment period).
* The treating doctor considers that changing a participant's cardiovascular medications would put the participant at risk (e.g. symptomatic heart failure, high dose βblocker required to manage angina or for rate control in atrial fibrillation,accelerated hypertension, severe renal insufficiency, a history of severe resistant hypertension)
* Known situation where medication regimen might be altered for a significant length of time, e.g. current acute cardiovascular event, planned coronary bypass graft operation.
* Unlikely to complete the trial (e.g. lifethreatening condition other than cardiovascular disease) or adhere to the trial procedures or attend study visits (e.g. major psychiatric condition, dementia).
D: Inclusion Criteria:

1. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic SBP greater than or equal to 160 and less than or equal to 190 mm Hg on Day -1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic SBP greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day -1.
2. Females of childbearing potential who are sexually active agree to routinely use adequate contraception from Screening through 30 days after the last administered study drug dose.
3. Has clinical laboratory test results (clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.
4. Is willing to discontinue current antihypertensive medications on Day -21 or Day -28 if the participant is on amlodipine or chlorthalidone.

Exclusion Criteria:

1. Has a mean sitting clinic diastolic blood pressure greater than 119 mm Hg on Day -1.
2. Has a baseline 24-hour ambulatory blood pressure monitoring reading of insufficient quality.
3. Works a night (third) shift (defined as 11 PM \[2300\] to 7 AM \[0700\]).
4. Has an upper arm circumference less than 24 cm or greater than 42 cm.
5. Is noncompliant (less than 70% or greater than 130%) with study medication during the placebo run-in period.
6. Has secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
7. Has a recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
8. Has clinically significant cardiac conduction defects (ie, third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, or atrial flutter).
9. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
10. Has severe renal dysfunction or disease \[based on estimated glomerular filtration rate less than 30 mL/min/1.73m2 at Screening\].
11. Has known or suspected unilateral or bilateral renal artery stenosis.
12. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those participants with basal cell or stage I squamous cell carcinoma of the skin).
13. Has poorly-controlled type 1 or type 2 diabetes mellitus at Screening.
14. Has hypokalemia or hyperkalemia (defined as serum potassium outside of the normal reference range of the central laboratory).
15. Has an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
16. Has any other known serious disease or condition that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.
17. Has known hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics or other sulfonamide-derived compounds.
18. Has been randomized in a previous azilsartan medoxomil study.
19. Currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to Screening.
20. Has a history of drug abuse or a history of alcohol abuse within the past 2 years.

Answer: B