Clinical trial · Interventional
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients
NCT01048047CI-TRIAL-00003021unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aliskiren/amlodipine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- aliskiren/amlodipine
- description
- aliskiren, 300 mg/amlodipine 10 mg
- interventionNames
- Drug: aliskiren/amlodipine
- type
- ACTIVE_COMPARATOR
- label
- amlodipine
- description
- amlodipine 10 mg
- interventionNames
- Drug: aliskiren/amlodipine
Primary outcomes (1)
- measure
- Blood pressure, heart rate, ankle-foot volume
- timeFrame
- At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * diastolic blood pressure \> 95 mmHg and \< 110 mmHg * systolic blood pressure \> 140 mmHg and \< 180 mmHg * no amlodipine therapy for the previous 6 months Exclusion Criteria: * diastolic blood pressure \> 110 mmHg and or * systolic blood pressure \> 180 mmHg * secondary hypertension * heart failure * diabetes mellitus * liver or kidney diseases
References
Publications (0)
Data not yet available
No reference posted for this study.