Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements

Study Overview
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Brief Summary
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Almost 50% of hypertensive patients remain uncontrolled. Clinical decisions are mostly based on office blood pressure,despite 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.

Detailed Description
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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 2,3,4 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≤ 130/80 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 (S)AE reporting.

Official Title
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Treatment of Essential Hypertension With Rasilez. Evaluation of Different Methods of Blood Pressure Measurements - Efficacy and Safety Evaluation

Conditions
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Blood Pressure, High

Intervention / Treatment
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* Drug: Aliskiren


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Essential hypertension at visit 1 defined as office blood pressure <140/90 mmHg and a 24 h ABPM >130/80 mmHg with a day time BP (extracted from the 24h ABPM) >135/85 mmHg Male and female Age 18-80 Every patient that in the medical opinion of the treating physician is eligible for Rasilez treatment Willing to sign an informed consent Exclusion Criteria: Use of more then 1 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs) Use of ACEI or ARB at base line visit Pregnant women WOCB - (will follow the usual limitations) Use of certain medications (e.g. Cyclosporine, Verapamil, Quinidine) Uncontrolled DM (investigator decision) Any of the following in the last six months: MI, Stroke, CABG, PTCI Congestive HF requiring pharmacological treatment Renal Failure, defined as serum creatinine equal or great than 1.5 mg% [confirmed twice] or hyperkalemia defined as serum potassium equal or great that 5 meq/l [confirmed twice] Malignancy that required Chemotherapy in the last 3 years Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren<br>only one arm with the experimental drug [aliskiren] | Drug: Aliskiren<br>* 150 mg during the first two weeks , 300 mg for another 10 weeks<br>* Other names: Self measured home blood pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with controlled blood pressure with office BP measurements, nurse measurements and SBPM, from baseline to week 12, compared and ABPM. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the SBP/DBP lowering efficacy of Rasilez treatment in patients with essential hypertension as measured by 4 different methods - 24h Ambulatory BP measurement, Office BP, Home BP and Nurse BP measurement. |  | 12 weeks | 
| To assess patient adherence to treatment. |  | 2, 6 and 12 weeks | 
| To evaluate the safety profile of Rasilez treatment in patients with essential hypertension. |  | 2, 6 and 12 weeks | 
| Evaluate the antihypertensive effect of Rasilez in real life, based on the 24h ABPM changes from base line to week 12. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, aliskiren, Blood Pressure Monitoring, Ambulatory