Phase 3
N=564
A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00667719 ↗Enrolled (actual)
564
Serious AEs
0.9%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death — 57; 54; 255; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aliskiren (Drug); Amlodipine (Drug); Hydrochlorothiazide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Oct 2009
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 | — |
Summary
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
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). 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.