Phase 4
N=256
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Essential Hypertension ( Mild to Moderate)
Bottom Line
View on ClinicalTrials.gov: NCT00765947 ↗Enrolled (actual)
256
Serious AEs
0.5%
Results posted
Jan 2011
Primary outcome: Primary: Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen — 86.12 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug); Hydrochlorothiazide (Drug); Amlodipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen |
86.12 | — |
| SECONDARY 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. |
91.48; 79.24; 92.74; 72.58 | — |
| SECONDARY Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] |
-25.33; -12.40 | — |
| SECONDARY Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] |
96.80; 97.78 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00765947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.