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

• ClinicalTrials.gov Identifier: NCT01080768
• Recruitment Status: Terminated
• First Posted: March 4, 2010
• Results First Posted: December 26, 2011
• Last Update Posted: December 26, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Ankle Edema	Drug: Aliskiren/amlodipine; Drug: Amlodipine; Drug: Placebo to Aliskiren/amlodipine; Drug: Placebo to Amlodipine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: February 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aliskiren/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.	Drug: Aliskiren/amlodipine; Aliskiren/amlodipine 150/5 mg/day; Other Name: SPA100; Drug: Placebo to Amlodipine; Placebo to Amlodipine 5 mg/day
Active Comparator: 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.	Drug: Amlodipine; Amlodipine 5 mg/day.; Drug: Placebo to Aliskiren/amlodipine; Placebo to Aliskiren/amlodipine 150/10 mg/day

Outcome Measures

Primary Outcome Measures :

1. Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

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, Netherlands

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01080768
• Other Study ID Numbers: CSPA100A2201; 2009-014359-63 ( EudraCT Number )
• First Posted: March 4, 2010
• Results First Posted: December 26, 2011
• Last Update Posted: December 26, 2011
• Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Pedal edema; hypertension; aliskiren; amlodipine

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Amlodipine; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents