Please select the arm or intervention descriptions that belong 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: Arm Label: FDC Fixed Dose Combination; Type: EXPERIMENTAL; Interventions: Drug: FDC | Arm Label: Conventional treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Separately drugs, simvastatin, aspirin and ramipril | Intervention Type: DRUG; Name: FDC; Assigned to Arm(s): FDC Fixed Dose Combination | Intervention Type: DRUG; Name: Separately drugs, simvastatin, aspirin and ramipril; Assigned to Arm(s): Conventional treatment
B: Arm Label: 1, POLYCAP; Type: EXPERIMENTAL; Interventions: Drug: POLYCAP | Arm Label: 2 B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Thiazides | Arm Label: 3 C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ramipril with Thiazide | Arm Label: 4 D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Thiazide plus atenolol | Arm Label: 5, E; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ramipril plus atenolol | Arm Label: 6, F; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ramipril plus atenolol plus thiazide | Arm Label: 7,G; Type: ACTIVE_COMPARATOR; Interventions: Drug: Thiazide + Ramipril+Atenolol+Aspirin | Arm Label: 8,H; Type: ACTIVE_COMPARATOR; Interventions: Drug: Simvastatin | Arm Label: 9,A; Type: ACTIVE_COMPARATOR; Interventions: Drug: aspirin | Intervention Type: DRUG; Name: Thiazides; Assigned to Arm(s): 2 B | Intervention Type: DRUG; Name: Ramipril with Thiazide; Assigned to Arm(s): 3 C | Intervention Type: DRUG; Name: Thiazide plus atenolol; Assigned to Arm(s): 4 D | Intervention Type: DRUG; Name: Ramipril plus atenolol; Assigned to Arm(s): 5, E | Intervention Type: DRUG; Name: Ramipril plus atenolol plus thiazide; Assigned to Arm(s): 6, F | Intervention Type: DRUG; Name: POLYCAP; Assigned to Arm(s): 1, POLYCAP | Intervention Type: DRUG; Name: Thiazide + Ramipril+Atenolol+Aspirin; Assigned to Arm(s): 7,G | Intervention Type: DRUG; Name: Simvastatin; Assigned to Arm(s): 8,H | Intervention Type: DRUG; Name: aspirin; Assigned to Arm(s): 9,A
C: Intervention Type: DRUG; Name: Amlodipine/Atorvastatin; Assigned to Arm(s): N/A
D: Intervention Type: DRUG; Name: fixed-dose combination of telmisartan 40mg+amlodipine 10mg; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: fixed-dose combination of telmisartan 80mg+amlodipine10mg; Assigned to Arm(s): N/A

Answer: B