A Phase 3 interventional study of Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) and Aliskiren (300 mg) in Hypertension, sponsored by Novartis. Completed at 8 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-30.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 688 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.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
Drug: Aliskiren (300 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time frame: Baseline to end of study (Week 12)
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time frame: Baseline to Week 8
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time frame: Baseline to Week 12
Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Time frame: Baseline to Week 12
| Milestone | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| Started | 349 | 339 |
| Completed | 326 | 293 |
| Not completed | 23 | 46 |
| Withdrew: Abnormal laboratory value(s) | 0 | 3 |
| Withdrew: Abnormal test procedure result(s) | 2 | 12 |
| Withdrew: Adverse event | 11 | 15 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Protocol violation | 2 | 2 |
| Withdrew: Withdrawal by subject | 5 | 10 |
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
| mm Hg | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12) | -30.01 ± 1.053 | -20.29 ± 1.067 |
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
| mm Hg | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8 | -30.09 ± 1.079 | -20.75 ± 1.094 |
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
| mm Hg | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| Baseline to Week 8 | -13.69 ± 0.599 | -7.99 ± 0.607 |
| Baseline to Week 12 | -12.64 ± 0.590 | -8.18 ± 0.598 |
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
| Percentage | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| Baseline to Week 8 | 53.5 | 30.4 |
| Baseline to Week 12 | 54.6 | 32.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | — | 2/349 (0.6%) | 27/349 (7.7%) |
| Aliskiren (300 mg) | — | 4/339 (1.2%) | 34/339 (10%) |
| Event | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| NephrolithiasisRenal and urinary disorders | 0/349 | 2/339 |
| VertigoEar and labyrinth disorders | 0/349 | 1/339 |
| Fracture displacementInjury, poisoning and procedural complications | 0/349 | 1/339 |
| Radius fractureInjury, poisoning and procedural complications | 0/349 | 1/339 |
| HaemorrhoidsGastrointestinal disorders | 1/349 | 0/339 |
| Tendon ruptureInjury, poisoning and procedural complications | 1/349 | 0/339 |
| Event | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) |
|---|---|---|
| HeadacheNervous system disorders | 14/349 | 29/339 |
| DizzinessNervous system disorders | 19/349 | 10/339 |
| Age Continuous(years) | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) | Total |
|---|---|---|---|
| Mean | 57.4 ± 10.33 | 56.4 ± 10.73 | 56.9 ± 10.53 |
| Sex: Female, Male(Participants) | Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg) | Aliskiren (300 mg) | Total |
|---|---|---|---|
| Female | 169 | 172 | 341 |
| Male | 180 | 167 | 347 |
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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