Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Double Blind Controlled Trial of the Efficacy and Safety of POLYCAP (Quintapill)Versus Its Components in Subjects With at Least One Additional Cardiovascular Risk Factor
Brief Summary: STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.

STUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.

STUDY DESIGN

Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.

STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.

INVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.

There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.

OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

STATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \[as measured by urinary thromboxane\] when compared with its different components in eight different formulations.


Options:
A: Inclusion Criteria:

* Phase 1: All patients, male and female, 40 years of age or older, with a history of ST-elevation AMI within the last 2 years, attending any of the selected sites and signing the consent
* Phase 2: All patients, male and female, 40 years of age or older, with a history of ST-elevation AMI within the last 2 years, attending any of the selected sites and signing the consent Patients in whom secondary prevention with ASA, statin and ACEI is indicated, Signing informed consent

Exclusion Criteria:

* Phase 1: Patients in which any of the components of the FDC is contraindicated. Living in a nursing home. Memtal illness limiting the capacity of
* Phase 2:Secondary dyslipemia, Patients in which any of the components of the FDC is contraindicated, Living in a nursing home, Mental illness limiting the capacity of self care, Participating in another trial, , Previous Percutaneous Transluminal Coronary Angioplasty (PTCA) with a drug eluting stent (DES) whitin the last year, Severe Congestive Heart Failure (NYHA III-IV), Serum creatinine \>2 mg/dl, any condition limiting life expectancy \<2 years. Pregnant or premenopausal women.
B: Inclusion Criteria:

* Age between 45 and 80 years
* At least any one of the following CVD risk factors:

  * Stable type 2 diabetes mellitus or
  * Hypertension or
  * Current smoker or
  * A waist to hip ratio \> 0.85 for women and \>0.9 for men or
  * Elevated lipids.
* Informed consent.

Exclusion Criteria:

* On any of the study medications,
* Uncontrolled blood pressure,
* Symptomatic hypotension,
* Any clear indication or a contraindication to the use of any of the study medications,
* History of coronary/cerebrovascular events,
* Pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.
C: Inclusion Criteria:

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

Exclusion Criteria:

* High liver enzymes
D: Inclusion Criteria:

- diagnosis of essential hypertension

Exclusion Criteria:

* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
* development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
* discontinuation from the preceding trial.
* known or suspected secondary hypertension.
* mean seated systolic blood pressure (SBP) \>= 180 mmHg and/or mean seated diastolic blood pressure (DBP) \>= 120 mmHg at any visit.
* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
* clinically relevant hyperkalaemia.
* uncorrected volume or sodium depletion.
* primary aldosteronism.
* hereditary fructose or lactose intolerance.
* symptomatic congestive heart failure.
* patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
* any new drug or alcohol dependency since signing consent of the preceding trial.
* concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
* known allergic hypersensitivity to any component of the formulations under investigation. \[Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).\] non-compliance with study medication (defined as \<80% or \>120%) during the preceding trial.
* administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.

Answer: B