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

Primary Purpose

Essential Hypertension ( Mild to Moderate)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aliskiren
Hydrochlorothiazide
Amlodipine
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension ( Mild to Moderate) focused on measuring Essential Hypertension ( mild to moderate)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aliskiren-based regimen

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
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.

Secondary Outcome Measures

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.
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]
Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]
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).

Full Information

First Posted
October 2, 2008
Last Updated
July 23, 2020
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00765947
Brief Title
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (Actual)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension ( Mild to Moderate)
Keywords
Essential Hypertension ( mild to moderate)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren-based regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Intervention Description
Aliskiren 150 or 300 mg
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Hydrochlorothiazide 12.5 or 25 mg
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine 5 or 10 mg
Primary Outcome Measure Information:
Title
Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 weeks
Title
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
Title
Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]
Description
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).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigative Site
City
Paris
Country
France
Facility Name
Investigative Site
City
Budapest
Country
Hungary
Facility Name
Investigative Site
City
Bucharest
Country
Romania
Facility Name
Investigative Site
City
Bratislava
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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