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.

Phase 2

Recruiting

• Conditions: high blood pressure; hypertension; 10057166

• Registration Number: NL-OMON35085
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

- Male or female 18-75 yrs old
- Mild to moderate hypertension
- Amlopdipine naïve
- Body mass index (BMI) must be 18-32 kg/m2

Exclusion Criteria

- Inability of the subjects to switch from all prior antihypertensive medications
- Severe hypertension at screening or baseline.
- Heart failure
- T1DM / T2DM

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in ankle foot volume (AFV) between baseline and after 4 weeks<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Blood pressure at different time points, ECG evaluations and standard clinical<br /><br>laboratory evaluations (hematology, blood chemistry, urinalysis). </p><br>