Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Increasing Stay-on-therapy in Hypertensive Patients Treated With First-line Diuretics: An Active Pharmacosurveillance and Pharmacogenetic Study.
Brief Summary: Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely considered a first line treatment, given the efficacy and low cost of this class of drugs. This indication is not unanimous, because thiazides can cause metabolic alterations and other side effects increasing cardiac and cerebrovascular risk, which reduce compliance to treatment and increase health care system cost. However, large intervention trials in HT suggest that the improvement in cardiovascular prognosis of HT patients depends more on follow-up procedures than on type of drug used. Furthermore, the investigators have documented improved compliance to antihypertensive therapy by implementing cooperation between general practitioners (GPs) and HT specialists.

Objectives: In a multicenter, open label randomized study the investigators will compare the persistence on therapy of thiazides versus other treatments, as a first line antihypertensive therapy, in a clinical setting characterized by a strict cooperation between GPs and HT specialist. The investigators will also analyse candidate genes with impact on drug-induced metabolic alterations to elucidate the pathophysiology of these phenomena.

Methods: 260 GPs will recruit 2600 hypertensive patients with indication to pharmacological treatment and randomise them to starting treatment with chlortalidone (12.5 to 25 mg daily, 1300 pts) or a GP decided single drug (excluding thiazides) or combination therapy at highest tolerated dose. In both groups any other class of antihypertensive drugs can be added over time in order to achieve blood pressure control (\<140/90 mmHg). Follow-up will last 2 years. Blood sample and urine analyses, carotid and cardiac ultrasound will be performed at baseline and scheduled time points. Genotyping will be performed by sequencing. Data will be collected and stored using a web based centralized Case Report Form (CRF) Expected results: Results will highlight whether a follow-up strategy based on tight cooperation between GPs and HT specialists can allow the use of thiazides as first line antihypertensive therapy without any negative effect on persistence, adherence and efficacy of the treatment. These data can be used to reduce total burden of the Health Care System in HT by replacing more expensive drugs with diuretics in the 50% of hypertensive patients, who do not receive this class of drugs. Furthermore, the pharmacogenetic approach may clarify the pathophysiological mechanisms of drug-induced metabolic side effects


Options:
A: Intervention Type: DRUG; Name: Aliskiren; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: Inhibitors, ACE; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: amlodipine; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: lisinopril; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: doxazosin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: chlorthalidone; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: pravastatin; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A
C: Arm Label: Benazepril/amlodipine; Type: EXPERIMENTAL; Interventions: Drug: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1, Drug: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2, Drug: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter | Arm Label: Benazepril/hydrochlorothiazide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1, Drug: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2, Drug: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter | Intervention Type: DRUG; Name: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1; Assigned to Arm(s): Benazepril/amlodipine | Intervention Type: DRUG; Name: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2; Assigned to Arm(s): Benazepril/amlodipine | Intervention Type: DRUG; Name: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter; Assigned to Arm(s): Benazepril/amlodipine | Intervention Type: DRUG; Name: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1; Assigned to Arm(s): Benazepril/hydrochlorothiazide | Intervention Type: DRUG; Name: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2; Assigned to Arm(s): Benazepril/hydrochlorothiazide | Intervention Type: DRUG; Name: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter; Assigned to Arm(s): Benazepril/hydrochlorothiazide
D: Arm Label: Thiazides; Type: ACTIVE_COMPARATOR; Interventions: Drug: thiazides | Arm Label: Non Tiazidic; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Non thiazidic treatment | Intervention Type: DRUG; Name: thiazides; Assigned to Arm(s): Thiazides | Intervention Type: PROCEDURE; Name: Non thiazidic treatment; Assigned to Arm(s): Non Tiazidic

Answer: D