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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions: |
Post Acute Coronary Syndrome Myocardial Ischemia |
| Interventions: |
Drug: Placebo Drug: Aliskiren 300 mg Drug: Valsartan 320 mg Drug: Aliskiren/valsartan 300/320 mg |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Placebo | Placebo tablets and capsules |
| Aliskiren 300 mg | Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. |
| Valsartan 320 mg | Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. |
| Aliskiren/Valsartan 300/320 mg | Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. |
| Placebo | Aliskiren 300 mg | Valsartan 320 mg | Aliskiren/Valsartan 300/320 mg | |
|---|---|---|---|---|
| STARTED | 280 | 271 | 269 | 281 |
| COMPLETED | 228 | 201 | 215 | 214 |
| NOT COMPLETED | 52 | 70 | 54 | 67 |
| Adverse Event | 27 | 37 | 25 | 33 |
| Abnormal laboratory value(s) | 2 | 2 | 2 | 4 |
| Lack of Efficacy | 0 | 0 | 0 | 2 |
| Subject no longer requires study drug | 0 | 0 | 0 | 1 |
| Withdrawal by Subject | 8 | 15 | 16 | 17 |
| Lost to Follow-up | 2 | 0 | 2 | 2 |
| Administrative problems | 8 | 9 | 2 | 4 |
| Death | 2 | 4 | 4 | 2 |
| Protocol Violation | 3 | 2 | 3 | 1 |
| Missing | 0 | 1 | 0 | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Placebo | Placebo tablets and capsules |
| Aliskiren 300 mg | Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. |
| Valsartan 320 mg | Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. |
| Aliskiren/Valsartan 300/320 mg | Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study. |
| Placebo | Aliskiren 300 mg | Valsartan 320 mg | Aliskiren/Valsartan 300/320 mg | Total | |
|---|---|---|---|---|---|
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Number of Participants
[units: participants] |
280 | 271 | 269 | 281 | 1101 |
|
Age
[units: years] Mean ± Standard Deviation |
63 ± 11.8 | 63 ± 11.7 | 64 ± 11.6 | 63 ± 11.1 | 63 ± 11.6 |
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Gender
[units: participants] |
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| Female | 103 | 86 | 72 | 87 | 348 |
| Male | 177 | 185 | 197 | 194 | 753 |
Outcome Measures
| 1. Primary: | Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8 [ Time Frame: Baseline to Week 8 ] |
| 2. Secondary: | Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8 [ Time Frame: Baseline to Week 8 ] |
| 3. Secondary: | Percentage of Patients With a Cardiac Event [ Time Frame: Baseline to Week 8 ] |
| 4. Secondary: | Percentage of Patients With a Composite Clinical-biochemical Event [ Time Frame: Baseline to Week 8 ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00409578 History of Changes |
| Other Study ID Numbers: | CSPP100A2347 |
| Study First Received: | December 7, 2006 |
| Results First Received: | January 11, 2011 |
| Last Updated: | April 15, 2011 |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |