|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Heart Care Foundation |
|---|---|
| Information provided by: | Heart Care Foundation |
| ClinicalTrials.gov Identifier: | NCT00421863 |
Purpose
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:
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Triatec 10 mg Drug: Triatec HCT 5 Drug: Lasix 25 Drug: Micardis 80 mg Drug: Micardis plus 80/12.5 Drug: Catapresan TTS 2 Drug: Norvasc 10 mg Drug: Triatec 5 mg Drug: Pluscor |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study |
| Enrollment: | 1111 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Intensive Strategy |
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).
|
| Usual Strategy: No Intervention |
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).
|
Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 48 Study Locations| Study Chair: | Paolo Verdecchia, MD | Ospedale Silvestrini - Perugia |
More Information
| Responsible Party: | Heart Care Foundation ( Aldo P. Maggioni, MD ) |
| Study ID Numbers: | C 33 |
| Study First Received: | January 12, 2007 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00421863 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
hypertension systolic blood pressure |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Adrenergic Agonists Ramipril Sensory System Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Analgesics Sympatholytics |
Adrenergic alpha-Agonists Clonidine Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Hypertension |