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The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren/HCTZ 300/25 mg | Experimental |
| |
| HCTZ 25 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4 | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4 | Baseline and Week 4 | |
| Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
Other exclusions may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sites in USA | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21659626 | Derived | Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren/HCTZ | Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks |
| FG001 | HCTZ | Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren/HCTZ | Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks |
| BG001 | HCTZ | Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4 | Full analysis set | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 4 |
|
|
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One patient was excluded from this analysis as he/she was inadvertently randomized into the study but did not receive study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aliskiren / HCTZ | Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Hydrochlorothiazide | Drug | Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks |
|
| Baseline and Week 8 |
| Percentage of Responders at Week 4 and Week 8 | Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline | At 4 weeks and 8 weeks |
| Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 | Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg | At Weeks 4 and 8 |
| Abnormal test procedure result(s) |
|
| Lack of Efficacy |
|
| Protocol deviation |
|
| Patient withdrew consent |
|
| Lost to Follow-up |
|
| Administrative Problems |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4 | Full analysis set, restricted to baseline msDBP >= 90 mmHg | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 4 |
|
|
|
| Secondary | Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 | Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg) | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline and Week 8 |
|
|
|
| Secondary | Percentage of Responders at Week 4 and Week 8 | Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline | Full analysis set | Posted | Number | Percentage of Participants | At 4 weeks and 8 weeks |
|
|
|
| Secondary | Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 | Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg | Full analysis set | Posted | Number | Percentage of Participants | At Weeks 4 and 8 |
|
|
|
| 4 |
| 227 |
| 17 |
| 227 |
| EG001 | HCTZ | HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks | 3 | 223 | 26 | 223 |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |