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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01080768
Other study ID # CSPA100A2201
Secondary ID 2009-014359-63
Status Terminated
Phase Phase 2
First received March 3, 2010
Last updated November 22, 2011
Start date February 2010
Est. completion date November 2010

Study information

Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Other protocol-defined inclusion/exclusion criteria are applied

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Aliskiren/amlodipine
Aliskiren/amlodipine 150/5 mg/day
Amlodipine
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipine
Placebo to Aliskiren/amlodipine 150/10 mg/day
Placebo to Amlodipine
Placebo to Amlodipine 5 mg/day

Locations

Country Name City State
Netherlands Novartis Investigative Site Beek en Donk
Netherlands Novartis Investigative Site Bosch
Netherlands Novartis Investigative Site Den Haag
Netherlands Novartis Investigative Site Hoogwoud
Netherlands Novartis Investigative Site Lichtenvoorde
Netherlands Novartis Investigative Site Lieshout
Netherlands Novartis Investigative Site Poortvliet
Netherlands Novartis Investigative Site Utrecht
Netherlands Novartis Investigative Site Wildervank

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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