Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Collaborator: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. 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

2. Male and female

3. Age 18-80

4. Every patient that in the medical opinion of the treating physician is eligible for Rasilez treatment

5. Willing to sign an informed consent

Exclusion Criteria:

1. Use of more then 1 anti hypertensive medication at visit 1 (fixed combination is considered as two drugs)

2. Use of ACEI or ARB at base line visit

3. Pregnant women

4. WOCB - (will follow the usual limitations)

5. Use of certain medications (e.g. Cyclosporine, Verapamil, Quinidine)

6. Uncontrolled DM (investigator decision)

7. Any of the following in the last six months: MI, Stroke, CABG, PTCI

8. Congestive HF requiring pharmacological treatment

9. 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]

10. Malignancy that required Chemotherapy in the last 3 years

11. Any medical or none medical condition that in the eyes of the investigator will not allow the patient to complete the study