Phase 4
Completed N=590
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
Source: ClinicalTrials.gov NCT01570686 ↗Enrolled (actual)
590
Serious AEs
1.0%
Results posted
Jan 2014
Primary outcomePrimary: Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) — -7.03; -7.79 mmHg
Summary
The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) |
-7.03; -7.79 | — |
| SECONDARY Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) |
-4.01; -4.39 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control |
44.7; 41.5 | — |
| SECONDARY Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) |
-13.65; -13.98; -8.97; -8.56 | — |
| SECONDARY Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction |
54.9; 55.8 | — |
| SECONDARY Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed |
108; 273; 102; 252 | — |
| SECONDARY Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed |
872; 1580; 1100; 1540 | — |
| SECONDARY Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed |
2.60; 1.71; 3.33; 1.72 | — |
| SECONDARY Change From Baseline to Week 8 in Plasma Renin Activity (PRA) |
-0.519; -1.962 | — |
| SECONDARY Change From Baseline to Week 8 in Plasma Renin Concentration (PRC) |
37.881; 50.967 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Death |
73; 90; 4; 2; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
- Patients with an office BP ≥ 140/90 mmHg and 8%
- Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome
Other protocol-defined inclusion/exclusion criteria may apply.
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Data sourced from ClinicalTrials.gov (NCT01570686). 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.