A Phase 3 interventional study of Aliskiren 300 mg and Aliskiren/Amlodipine 300/5 mg in Hypertension, sponsored by Novartis. Completed at 9 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-12.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 818 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
Drug: Aliskiren/Amlodipine 300/5 mg · Drug: Placebo to Aliskiren
Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.
Drug: Aliskiren/Amlodipine 300/10 mg · Drug: Placebo to Aliskiren
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
Drug: Aliskiren 300 mg · Drug: Placebo to Aliskiren/Amlodipine
Aliskiren 300 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
Placebo to Aliskiren tablet taken orally once a day.
Placebo to Aliskiren/Amlodipine taken orally once a day.
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
Time frame: Baseline, End of Study (Week 8)
Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
Time frame: Baseline, End of Study (Week 8)
Number of Participants With Serious Adverse Events and Adverse Events
The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section.
Time frame: 8 weeks
Percentage of Participants Achieving Blood Pressure Control
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure \<90 and a mean sitting Systolic Blood Pressure \<140.
Time frame: 8 weeks
Percentage of Participants Achieving a Diastolic Blood Pressure Response
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) \<90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.
Time frame: 8 weeks
Percentage of Participants Achieving a Systolic Blood Pressure Response
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) \<140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
Time frame: 8 weeks
| Milestone | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Started | 283 | 277 | 260 |
| Safety & full analysis sets | 282 | 276 | 260 |
| Completed | 262 | 271 | 244 |
| Not completed | 21 | 6 | 16 |
| Withdrew: Adverse event | 11 | 1 | 3 |
| Withdrew: Lack of efficacy | 0 | 0 | 9 |
| Withdrew: Condition no longer required study drug | 1 | 0 | 0 |
| Withdrew: Patient withdrew consent | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 3 | 1 | 0 |
| Withdrew: Protocol deviation | 2 | 1 | 1 |
| Withdrew: Randomized in error | 1 | 1 | 0 |
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
| mm Hg | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP) | -13.07 ± 0.463 | -10.54 ± 0.467 | -5.84 ± 0.480 |
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.
| mm Hg | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP) | -18.04 ± 0.780 | -14.43 ± 0.788 | -6.42 ± 0.809 |
The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class. Additional information about Adverse Events can be found in the Adverse Event Section.
| participants | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Serious Adverse Events | 3 | 4 | 1 |
| Adverse Events | 85 | 80 | 59 |
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure \<90 and a mean sitting Systolic Blood Pressure \<140.
| Percentage of participants | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Percentage of Participants Achieving Blood Pressure Control | 65.5 | 56.5 | 31.5 |
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) \<90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline.
| Percentage of participants | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Percentage of Participants Achieving a Diastolic Blood Pressure Response | 83.6 | 77.7 | 51.5 |
After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) \<140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline.
| Percentage of participants | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Percentage of Participants Achieving a Systolic Blood Pressure Response | 77.2 | 69.7 | 43.8 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aliskiren 300 mg/Amlodipine 10 mg | — | 3/282 (1.1%) | 26/282 (9.2%) |
| Aliskiren 300 mg/Amlodipine 5 mg | — | 4/276 (1.4%) | 6/276 (2.2%) |
| Aliskiren 300 mg | — | 1/260 (0.4%) | 1/260 (0.4%) |
| Event | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Post-traumatic painInjury, poisoning and procedural complications | 0/282 | 0/276 | 1/260 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/282 | 0/276 | 1/260 |
| VertigoEar and labyrinth disorders | 0/282 | 1/276 | 0/260 |
| PyrexiaGeneral disorders | 0/282 | 1/276 | 0/260 |
| Viral infectionInfections and infestations | 0/282 | 1/276 | 0/260 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/282 | 1/276 | 0/260 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/282 | 1/276 | 0/260 |
| Drug hypersensitivityImmune system disorders | 1/282 | 0/276 | 0/260 |
| Lobar pneumoniaInfections and infestations | 1/282 | 0/276 | 0/260 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/282 | 0/276 | 0/260 |
| Event | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg |
|---|---|---|---|
| Oedema peripheralGeneral disorders | 26/282 | 6/276 | 1/260 |
| Age Continuous(years) | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg | Total |
|---|---|---|---|---|
| Mean | 54.6 ± 10.67 | 54.4 ± 10.69 | 54.7 ± 10.99 | 54.6 ± 10.77 |
| Sex: Female, Male(Participants) | Aliskiren 300 mg/Amlodipine 10 mg | Aliskiren 300 mg/Amlodipine 5 mg | Aliskiren 300 mg | Total |
|---|---|---|---|---|
| Female | 120 | 101 | 103 | 324 |
| Male | 163 | 176 | 157 | 496 |
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