Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

Phase 2

Terminated

• Conditions: Ankle Edema; Hypertension
• Interventions: Drug: Aliskiren/amlodipine; Drug: Amlodipine; Drug: Placebo to Aliskiren/amlodipine; Drug: Placebo to Amlodipine

• Registration Number: NCT01080768
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-11
• Results First Submitted: 2011-11-22
• Results First Submitted QC: 2011-11-22
• Last Update Submitted: 2011-11-22
• Results First Posted: 2011-12-26
• Last Update Posted: 2011-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren/amlodipine + Placebo to amlodipine	Aliskiren/amlodipine	During 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	Placebo to Aliskiren/amlodipine	During 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.
Amlodipine + Placebo to aliskiren/amlodipine	Amlodipine	During 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.
Aliskiren/amlodipine + Placebo to amlodipine	Placebo to Amlodipine	During 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.

Primary Outcome Measures

Name	Time	Method
Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method	Baseline, 4 weeks	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇳🇱 Wildervank, Netherlands