Phase 3
Completed N=564
A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
Source: ClinicalTrials.gov NCT00667719 ↗Enrolled (actual)
564
Serious AEs
0.9%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death — 57; 54; 255; 0 Participants
◆ Published Evidence
Emerging
11citations · ~1 / year
Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study.
Summary
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
Linked Publications
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Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death |
57; 54; 255; 0; 1; 14 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
101.8; -20.3; -21.8 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
166.1; -34.2; -37.3 | — |
| SECONDARY Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg |
69.1; 77.1 | — |
| SECONDARY Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure |
91.8; 96.6 | — |
| SECONDARY Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure |
90.2; 93.7 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatients 18 years of age or older
- Male or female participants are eligible.
- Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:
- For newly diagnosed/untreated participants, msDBP ≥ 100 and = 5 milli-international units per milliliter mIU/mL).
Data sourced from ClinicalTrials.gov (NCT00667719) and the linked publication. 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.