An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00402103
First received: November 18, 2006
Last updated: March 8, 2011
Last verified: March 2011
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Purpose
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren Drug: Amlodipine Drug: Hydrochlorothiazide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Overall Percentage of Patients With Adverse Events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54 ] [ Designated as safety issue: No ]
- Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg [ Time Frame: Baseline, Week 2, Week 10, Week 28 and Week 54 ] [ Designated as safety issue: No ]
- Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, Week 2, Week 10, Week 28 and Week 54 ] [ Designated as safety issue: No ]
| Enrollment: | 556 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aliskiren/Amlodipine |
Drug: Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
Drug: Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
|
| Experimental: Aliskiren/Amlodipine/HCTZ |
Drug: Aliskiren
All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration
Drug: Amlodipine
All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration
Drug: Hydrochlorothiazide
Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.
|
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 or older
- Male or female patients are eligible
- For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
Exclusion Criteria:
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of Hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402103
Locations
| United States, New Mexico | |
| Investigative Site | |
| Santa Fe, New Mexico, United States | |
| Belgium | |
| Investigator Site | |
| Investigative Site, Belgium | |
| Denmark | |
| Investigative Center | |
| Investigative Center, Denmark | |
| Finland | |
| Investigative Site | |
| Investigative Site, Finland | |
| Germany | |
| Investigative Center | |
| Investigative Center, Germany | |
| Iceland | |
| Investigative Site | |
| Investigative Site, Iceland | |
| India | |
| Investigative Site | |
| Investigative Site, India | |
| Switzerland | |
| Investigative Site | |
| Investigative Site, Switzerland | |
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00402103 History of Changes |
| Other Study ID Numbers: | CSPA100A2301 |
| Study First Received: | November 18, 2006 |
| Results First Received: | December 13, 2010 |
| Last Updated: | March 8, 2011 |
| Health Authority: | United States: Food and Drug Administration Belgium: Ministry of Social Affairs, Public Health and the Environment Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices India: Ministry of Health Switzerland: Swissmedic |
Keywords provided by Novartis:
|
Hypertension, aliskiren, amlodipine, HCTZ, blood pressure |
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 21, 2013