Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements

NCT01060865 | Terminated Phase 4 DMC

• 1 other identifier: CSPP100AIL02T
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure, High

Keywords

hypertension; aliskiren; Blood Pressure Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Aliskiren

EXPERIMENTAL

only one arm with the experimental drug \[aliskiren\]

Drug: Aliskiren

Interventions

Aliskiren DRUG

150 mg during the first two weeks , 300 mg for another 10 weeks

Also known as: Blood Pressure, Ambulatory Blood Pressure monitor, Self measured home blood pressure

Aliskiren

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Clalit health services

Herzliya, Hasharon Area, Israel

Location

Related Publications (8)

• Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Bush C, Keefe DL. Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in obese patients with hypertension: sub-analysis of a 52-week, randomized, double-blind trial. J Hypertens. 2009 Jul;27(7):1493-501. doi: 10.1097/HJH.0b013e32832be593.

  PMID: 19444142 BACKGROUND

• Gradman AH, Schmieder RE, Lins RL, Nussberger J, Chiang Y, Bedigian MP. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation. 2005 Mar 1;111(8):1012-8. doi: 10.1161/01.CIR.0000156466.02908.ED. Epub 2005 Feb 21.

  PMID: 15723979 BACKGROUND

• Uresin Y, Taylor AA, Kilo C, Tschope D, Santonastaso M, Ibram G, Fang H, Satlin A. Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension. J Renin Angiotensin Aldosterone Syst. 2007 Dec;8(4):190-8. doi: 10.3317/jraas.2007.028.

  PMID: 18205098 BACKGROUND

• Verdecchia P, Calvo C, Mockel V, Keeling L, Satlin A. Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension. Blood Press. 2007;16(6):381-91. doi: 10.1080/08037050701717014.

  PMID: 18058456 BACKGROUND

• Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension. 2007 May;49(5):1047-55. doi: 10.1161/HYPERTENSIONAHA.106.084301. Epub 2007 Mar 12.

  PMID: 17353513 BACKGROUND

• Burt VL, Cutler JA, Higgins M, Horan MJ, Labarthe D, Whelton P, Brown C, Roccella EJ. Trends in the prevalence, awareness, treatment, and control of hypertension in the adult US population. Data from the health examination surveys, 1960 to 1991. Hypertension. 1995 Jul;26(1):60-9. doi: 10.1161/01.hyp.26.1.60.

  PMID: 7607734 BACKGROUND

• Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.

  PMID: 15611362 BACKGROUND

• Dolan E, Stanton AV, Thom S, Caulfield M, Atkins N, McInnes G, Collier D, Dicker P, O'Brien E; ASCOT Investigators. Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patients--an Anglo-Scandinavian cardiac outcomes trial substudy. J Hypertens. 2009 Apr;27(4):876-85. doi: 10.1097/HJH.0b013e328322cd62.

  PMID: 19516185 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Blood Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Eduardo Podjarny, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2011-05

Locations

IL (1)