Phase 4
N=23
Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients
Hypertension · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01284114 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: The Change of Blood Pressure — -22.7; -5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Jichi Medical University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change of Blood Pressure |
-22.7; -5 | — |
| PRIMARY The Change of Heart Function Confirmed by Echocardiograph |
-0.3 | — |
| PRIMARY The Change of BNP |
6.7 | — |
| PRIMARY The Change of eGFR |
-0.9 | — |
| PRIMARY The Change of Urine Albumin/ Creatinine Ratio (UACR). |
-337.5 | — |
| SECONDARY The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM |
— | — |
Summary
The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Chronic kidney disease
- Clinical diagnosis of Hypertension (Blood pressure >=140/90mmHg)
- Elderly people(>=65 years old)
Exclusion Criteria
- The patients who are already taking aliskiren
- The patients who are receiving hemodialysis or peritoneal dialysis
- The patients who are taking cyclosporin
- The patients who have hyperkalemia(>=5.5mEq/ml)
- Severe heart failure (>=NYHA class III)
- Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (>=HbA1c 9.0&)
- Severe liver dysfunction (five folds increased AST or ALT than standard values)
Data sourced from ClinicalTrials.gov (NCT01284114). 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.