Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Tracking Information
First Submitted Date ICMJE	October 2, 2008
First Posted Date ICMJE	October 3, 2008
Results First Submitted Date	December 13, 2010
Results First Posted Date	January 11, 2011
Last Update Posted Date	March 11, 2011
Study Start Date ICMJE	September 2008
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 8, 2011)	Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen [ Time Frame: 24 weeks ]; For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.
Original Primary Outcome Measures ICMJE; (submitted: October 2, 2008)	Percentage of patients reaching BP target [ Time Frame: 24 weeks ]
Change History	Complete list of historical versions of study NCT00765947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 8, 2011)	Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. [ Time Frame: 24 weeks ]For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.; Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] [ Time Frame: Baseline and Week 24 ]; Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] [ Time Frame: 24 weeks ]Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).; Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: October 2, 2008)	Percentage of patients reaching BP target [ Time Frame: 24 weks ]; BP-lowering effect, msSBP/msDBP responder rate and control rates based on treatment algorithm [ Time Frame: 24 weeks ]; Responder rate for msSBP and for msDBP [ Time Frame: 24 weeks ]; Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment [ Time Frame: 24 weeks ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Official Title ICMJE	A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension.
Brief Summary	This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Essential Hypertension ( Mild to Moderate)
Intervention ICMJE	Drug: Aliskiren Aliskiren 150 or 300 mg; Drug: Hydrochlorothiazide Hydrochlorothiazide 12.5 or 25 mg; Drug: Amlodipine Amlodipine 5 or 10 mg
Study Arms	Experimental: Aliskiren-based regimen; All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.; Interventions: Drug: Aliskiren; Drug: Hydrochlorothiazide; Drug: Amlodipine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 21, 2009)	256
Original Estimated Enrollment ICMJE; (submitted: October 2, 2008)	230
Study Completion Date	August 2009
Actual Primary Completion Date	August 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Outpatients ≥ 18 years of age; Patients with a diagnosis of mild to moderate hypertension at Visit 1; All patients must have a msSBP ≥ 140 mmHg and < 180 mmHg and/or msDBP ≥ 90 mmHg and < 110 mmHg mmHg at Visit 3 Exclusion Criteria: Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg; Secondary form of hypertension; Current diagnosis of heart failure (NYHA Class II-IV); Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates); Second or third degree heart block without a pacemaker; Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France, Hungary, Romania, Slovakia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00765947
Other Study ID Numbers ICMJE	CSPP100A2360
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	External Affairs, Novartis
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Novartis
Verification Date	March 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP