Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01060865
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2010-02-01
Brief Title:
Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
Treatment of Essential Hypertension With Rasilez Evaluation of Different Methods of Blood Pressure Measurements - Efficacy and Safety Evaluation
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The participants signed an old version of the informed consent
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REALITY
Brief Summary:
Almost 50 of hypertensive patients remain uncontrolled Clinical decisions are mostly based on office blood pressuredespite the fallacies of this method of measurement Other reasons for not achieving blood pressure targets are lack of 24-hr efficacy and tolerability of existing anti-hypertensive drug classes Aliskiren Rasilez is a new antihypertensive drug given once a day
The purpose of the REALITY study-tREAtment of essentiaL hypertension with rasIlez evaluation of different methods of blood pressure measurements - efficacy and safeTY evaluation - is to evaluate the efficacy and tolerability of aliskiren in a real life setting The efficacy of the drug will be evaluated using 24 hour ambulatory blood pressure monitoring ABPM Results will be compared with office nurse or self blood pressure monitoring This comparison will allow to decide which follow-up technique is better for those hypertensive patients
The purpose of the REALITY study-tREAtment of essentiaL hypertension with rasIlez evaluation of different methods of blood pressure measurements - efficacy and safeTY evaluation - is to evaluate the efficacy and tolerability of aliskiren in a real life setting The efficacy of the drug will be evaluated using 24 hour ambulatory blood pressure monitoring ABPM Results will be compared with office nurse or self blood pressure monitoring This comparison will allow to decide which follow-up technique is better for those hypertensive patients
Detailed Description:
This is a single centre observational uncontrolled prospective study Hypertensive patients that are either treatment naïve or uncontrolled on current monotherapy and meet all inclusion and exclusion criteria will be assigned to Rasilez treatment start for 2 weeks on 150 mg and if well tolerated the dosage will be increased to 300 mg The treatment will then be continued for additional 10 weeks Rasilez can be administrated as monotherapy or as add on to other antihypertensive patients currently on single medication
The patient will have additional visits at week 6 and at week 12 For all eligible patients a 24 h ABPM test will be performed at the week prior to visit 2 treatment initiation and at the week prior to the final visit
Each patient will receive an automatic blood pressure monitor OMRON MX3 plus for SBPM measurements The monitor will be provided by the sponsor for the whole study period The patient will be trained for blood pressure measurements SBPM will be performed twice a week morning and evening Nurse blood pressure measurements will be performed at each visit after 10 minutes of rest prior to the medical visit
Office blood pressure will be performed by the physician at each visit Blood samples for electrolytes renal function liver function and hematology will be taken at base line visit at week 2 and at week 12 Other antihypertensive can be added at any time during the study according to the decision of the investigator except ACE inhibitors and ARBs
AEs have to be reported at the appropriate site on the CRF page In case of discontinuation of aliskiren or interruption of aliskiren treatment the reason has to be given Serious adverse events SAEs have to be documented additionally on the separate SAE form and have to be reported within 24h to the NOVARTIS Pharma Drug safety department Adherence to treatment will be evaluated using standard formulas Estimated time for recruitment of 50 patients One year Study design scheme Visit 1 -week -2 physician and nurse BP Sign inform consent- command ABPM a week prior to visit 2 - SBPM training Visit 2 week 0 physician and nurse BP Start Rasilez 150 mg and command laboratory exams prior to next visit
Visit 3 week 2 physician and nurse BP Titrate Rasilez to 300 mg Visit 4 week 6 physician and nurse BP ABPM and command lab exams a week prior to visit 5 Visit 5 12 weeks physician and nurse BP SBPM data will be collected at visit 234 and 5
Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to WHO and ESH for SBPM and ABPM criteria
Office Blood Pressure Diastolic blood pressure DBP 90 mmHg and Systolic blood pressure SBP 140 mmHg for non-diabetics or DBP 80 mmHg and SBP 130 mmHg for diabetics respectively
SBPM DBP 85 mmHg and SBP 135 mmHg 24 h ABPM DBP 13080 mmHg SBP 130 mmHg Awake DBP 85 mmHg Awake SBP 135 mmHg Asleep DBP 70 mmHg asleep SBP 70 mmHg Effectiveness and Safety will also be evaluated taking into consideration patient compliance
Safety assessments
Safety will be assessed by means of SAE reporting
The patient will have additional visits at week 6 and at week 12 For all eligible patients a 24 h ABPM test will be performed at the week prior to visit 2 treatment initiation and at the week prior to the final visit
Each patient will receive an automatic blood pressure monitor OMRON MX3 plus for SBPM measurements The monitor will be provided by the sponsor for the whole study period The patient will be trained for blood pressure measurements SBPM will be performed twice a week morning and evening Nurse blood pressure measurements will be performed at each visit after 10 minutes of rest prior to the medical visit
Office blood pressure will be performed by the physician at each visit Blood samples for electrolytes renal function liver function and hematology will be taken at base line visit at week 2 and at week 12 Other antihypertensive can be added at any time during the study according to the decision of the investigator except ACE inhibitors and ARBs
AEs have to be reported at the appropriate site on the CRF page In case of discontinuation of aliskiren or interruption of aliskiren treatment the reason has to be given Serious adverse events SAEs have to be documented additionally on the separate SAE form and have to be reported within 24h to the NOVARTIS Pharma Drug safety department Adherence to treatment will be evaluated using standard formulas Estimated time for recruitment of 50 patients One year Study design scheme Visit 1 -week -2 physician and nurse BP Sign inform consent- command ABPM a week prior to visit 2 - SBPM training Visit 2 week 0 physician and nurse BP Start Rasilez 150 mg and command laboratory exams prior to next visit
Visit 3 week 2 physician and nurse BP Titrate Rasilez to 300 mg Visit 4 week 6 physician and nurse BP ABPM and command lab exams a week prior to visit 5 Visit 5 12 weeks physician and nurse BP SBPM data will be collected at visit 234 and 5
Efficacy will be defined in terms of therapeutic goals expressed as target blood pressures according to WHO and ESH for SBPM and ABPM criteria
Office Blood Pressure Diastolic blood pressure DBP 90 mmHg and Systolic blood pressure SBP 140 mmHg for non-diabetics or DBP 80 mmHg and SBP 130 mmHg for diabetics respectively
SBPM DBP 85 mmHg and SBP 135 mmHg 24 h ABPM DBP 13080 mmHg SBP 130 mmHg Awake DBP 85 mmHg Awake SBP 135 mmHg Asleep DBP 70 mmHg asleep SBP 70 mmHg Effectiveness and Safety will also be evaluated taking into consideration patient compliance
Safety assessments
Safety will be assessed by means of SAE reporting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None