Phase 3
Completed N=1,342
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT01237223 ↗Enrolled (actual)
1,342
Serious AEs
0.4%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) — -5.21; -7.49; -9.46; -11.90 mm Hg
Summary
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110 mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) |
-5.21; -7.49; -9.46; -11.90; -12.40; -16.43 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) |
-4.57; -10.63; -13.16; -17.98; -18.15; -25.49 | — |
| SECONDARY Percentage of Participants Achieving Blood Pressure Control at Endpoint |
16.3; 25.5; 32.9; 50.0; 45.9; 69.2 | — |
| SECONDARY Percentage of Participants Achieving a Successful Response Rate |
34.6; 46.5; 50.6; 70.3; 65.4; 86.2 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
62; 57; 50; 49; 57; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
- Outpatients
Exclusion Criteria
- Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
- History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
- History or evidence of a secondary hypertension
Other protocol-defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT01237223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.