Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00765947
First received: October 2, 2008
Last updated: March 8, 2011
Last verified: March 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension ( Mild to Moderate) |
Drug: Aliskiren Drug: Hydrochlorothiazide Drug: Amlodipine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
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. [ 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 ]
| Enrollment: | 256 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Aliskiren
Aliskiren 150 or 300 mg
Drug: Hydrochlorothiazide
Hydrochlorothiazide 12.5 or 25 mg
Drug: Amlodipine
Amlodipine 5 or 10 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765947
Locations
| France | |
| Investigative Site | |
| Paris, France | |
| Hungary | |
| Investigative Site | |
| Budapest, Hungary | |
| Romania | |
| Investigative Site | |
| Bucharest, Romania | |
| Slovakia | |
| Investigative Site | |
| Bratislava, Slovakia | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00765947 History of Changes |
| Other Study ID Numbers: | CSPP100A2360 |
| Study First Received: | October 2, 2008 |
| Results First Received: | December 13, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy Slovakia: State Institute for Drug Control Romania: National Medicines Agency |
Keywords provided by Novartis:
|
Essential Hypertension ( mild to moderate) |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Amlodipine Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013