Study Stopped
Publication of data from a similar study made the current study redundant.
Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension
2 other identifiers
interventional
31
1 country
9
Brief Summary
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hypertension
Started Feb 2010
Shorter than P25 for phase_2 hypertension
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
December 26, 2011
CompletedDecember 26, 2011
November 1, 2011
9 months
March 3, 2010
November 22, 2011
November 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
Baseline, 4 weeks
Study Arms (2)
Aliskiren/amlodipine + Placebo to amlodipine
EXPERIMENTALDuring the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Amlodipine + Placebo to aliskiren/amlodipine
ACTIVE COMPARATORDuring the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Interventions
Aliskiren/amlodipine 150/5 mg/day
Placebo to Aliskiren/amlodipine 150/10 mg/day
Eligibility Criteria
You may qualify if:
- Patients (male or female) with hypertension aged between 18-75 yrs.
- Patients not treated with amlodipine or no amlodipine in previous 1 year.
- Post-menopausal females
You may not qualify if:
- Patients unable to switch from prior hypertensive medication.
- Severe hypertension.
- Pregnant or nursing females.
- Patients with Type 1 or Type 2 diabetes mellitus
- History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay \[ELISA\] and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Novartis Investigative Site
Beek en Donk, Netherlands
Novartis Investigative Site
Bosch, Netherlands
Novartis Investigative Site
Hoogwoud, Netherlands
Novartis Investigative Site
Lichtenvoorde, Netherlands
Novartis Investigative Site
Lieshout, Netherlands
Novartis Investigative Site
Poortvliet, Netherlands
Novartis Investigative Site
The Hague, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Wildervank, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2010
First Posted
March 4, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 26, 2011
Results First Posted
December 26, 2011
Record last verified: 2011-11