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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00765947
First received: October 2, 2008
Last updated: March 8, 2011
Last verified: March 2011

October 2, 2008
March 8, 2011
September 2008
August 2009   (final data collection date for primary outcome measure)
Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.
Percentage of patients reaching BP target [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00765947 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching BP target [ Time Frame: 24 weks ] [ Designated as safety issue: No ]
  • BP-lowering effect, msSBP/msDBP responder rate and control rates based on treatment algorithm [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rate for msSBP and for msDBP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Overall safety and tolerability of aliskiren monotherapy and in combination treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
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.

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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension ( Mild to Moderate)
  • Drug: Aliskiren
    Aliskiren 150 or 300 mg
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide 12.5 or 25 mg
  • Drug: Amlodipine
    Amlodipine 5 or 10 mg
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
August 2009
August 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Hungary,   Romania,   Slovakia
 
NCT00765947
CSPP100A2360
No
External Affairs, Novartis
Novartis
Not Provided
Not Provided
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP