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| Study to evaluate the efficacy and safety of candesartan and amlodipine combination in comparison to the valsartan and amlodipine association in the treatment of arterial hypertension stages 1 and 2 |
| ISRCTN | ISRCTN37087271 |
| ClinicalTrials.gov identifier | |
| Public title | Study to evaluate the efficacy and safety of candesartan and amlodipine combination in comparison to the valsartan and amlodipine association in the treatment of arterial hypertension stages 1 and 2 |
| Scientific title | Open label, prospective, parallel, multicenter and randomized study to evaluate the efficacy and safety of candesartan and amlodipine combination in comparison to the valsartan and amlodipine association in the treatment of arterial hypertension stages 1 and 2 |
| Acronym | N/A |
| Serial number at source | LB1106 |
| Study hypothesis | To show the non-inferiority of the new combination of candesartan and amlodipine compared to the valsartan and amlodipine association in the treatment of arterial hypertension stages 1 and 2 |
| Lay summary | Lay summary under review |
| Ethics approval | Hospital Universitario Pedro Ernesto (HUPE) Ethics Committee, Rio de Janeiro, Brazil, 24 November 2011 |
| Study design | Open label prospective parallel multicenter randomized trial |
| Countries of recruitment | Brazil |
| Disease/condition/study domain |
Hypertension stages 1 or 2
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| Participants - inclusion criteria |
1. Adult patients over 18 year-old from both genders
2. Informed consent form (ICF) signed by the participant 3. Patients diagnosed with hypertension stages 1 or 2, according to the definitions and orientations publicized in the VI Brazilian Arterial Hypertension Guidelines |
| Participants - exclusion criteria |
1. Fertile women, independently of the use of contraceptive methods
2. Arterial hypertension over or equal to 180 mmHg (systolic) or 110 mmHg (diastolic) or in use of more than two anti-hypertensive drugs at the same time 3. Known hypersensitivity to study medications 4. Non-adherence to the placebo treatment during the run-in period 5. Laboratory exams collected in the screening visit considered clinically significant by the investigator 6. ECG performed during the screening visit showing ventricular arrhythmia, atrium-ventricular block of 2nd or 3rd degree, arrhythmia, tachycardia, bradycardia, or any other alteration considered clinically significant by the investigator 7. Angina pectoris Canadian Cardiovascular Society (CCS) class III or IV 8. Decompensate angina pectoris New York Heart Association (NYHA) class II or IV 9. BMI over 35 kg/m2 10. Moderate or advanced hepatic insufficiency 11. Severe or decompensate kidney insufficiency, characterized by creatinine clearance lower than 30 mL/min/1,73 m2 of corporal surface or dialyses required 12. Ongoing severe conditions, even if controlled by therapy: gastrointestinal, immunological, cardiovascular or cancer 13. Presence or history of significant edema of lower limbs (++/4+ or more) 14. Myocardial infarction, myocardial revascularization or coronary angioplasty in the last 6 months or myocardial revascularization scheduled for the next 6 months 15. Significant or decompensate cardiac valvulopathy 16. Stroke or transient ischemic attack in the last 12 months or carotid revascularization scheduled for the next 6 months 17. Uncontrolled diabetes (HbA1C over 9%) 18. History of angioneurotic oedema 19. Baseline levels of potassium over than 5 mEq/L 20. Any relevant disease that by investigator judgment may interfere in the study objectives or patients’ risks 21. Psychiatric disease that prevent the patient to participate in the study or cognitive disturbs (demential syndrome of any origin) |
| Anticipated start date | 01/06/2012 |
| Anticipated end date | 31/01/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 228 |
| Interventions | Patients will receive either candesartan (8, 16 or 32 mg) plus amlodipine (5 mg) or valsartan (80, 160, 320 mg) plus amlodipine (5 mg). The total duration of the intervention is 15 weeks maximum (1 week for screening, 2 weeks for wash-out and 12 weeks for drug treatment). |
| Primary outcome measure(s) | Difference between the two treatment groups with respect to the mean values of systolic blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment |
| Secondary outcome measure(s) |
1. Difference between the two treatment groups with respect to the mean values of diastolic blood pressure (mmHg), measured by ABPM during 24 hours before and after treatment
2. Comparison of mean values of systolic and diastolic blood pressure during awake and sleep periods measured by ABPM during 24 hours before and after treatment 3. Proportion of deepers and non-deepers between the groups during sleep period before and after treatment 4. Difference in pulse pressure (24 hours and at clinic) between groups and intra-individual 5. Difference in systolic and diastolic blood pressure between the two treatment groups 6. Difference in the number of responders or controlled patients between the two treatment groups after 12 weeks of treatment |
| Sources of funding | Libbs Farmacetica Ltd. (Brazil) |
| Trial website | |
| Publications | |
| Contact name | Dr Jairo Borges |
| Address | Rua Josef Kryss, 250 |
| City/town | Sao Paulo |
| Zip/Postcode | 01140-050 |
| Country | Brazil |
| Sponsor | Libbs Farmacetica Ltda. (Brazil) |
| Address | Rua Josef Kryss, 250 |
| City/town | Sao Paulo - SP |
| Zip/Postcode | 01140-050 |
| Country | Brazil |
| Sponsor website: | http://www.libbs.com.br |
| Date applied | 25/11/2011 |
| Last edited | 19/12/2011 |
| Date ISRCTN assigned | 19/12/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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