NCT00421863

Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,111 (actual)
• Sponsor: Heart Care Foundation · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects \> 55 years and poorly controlled (systolic blood pressure \>= 150 mmHg) by antihypertensive treatment: * usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels; * intensive strategy: reduction of systolic blood pressure to below 130 mmHg, independently of diastolic blood pressure levels. During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure \>=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to one of the two blood pressure goals outlined above. Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).

Detailed description

Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Triatec 10 mg	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Triatec HCT 5	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Lasix 25	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Micardis 80 mg	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Micardis plus 80/12.5	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Catapresan TTS 2	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Norvasc 10 mg	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Triatec 5 mg	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).
DRUG	Pluscor	Use and dosage according to physician judgement, concomitant treatment assumed and randomization arm (Intensive Strategy vs. Usual Strategy).

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-01-15
• Last updated: 2021-02-03

Locations

45 sites across 1 country: Italy