Trial intelligence / Profile preview

Acute Effects of Cinacalcet on Arterial Stiffness in Hemodialysis

NCT01250405Phase 4

Key facts

Status
Completed
Start
May 2012
Primary completion
Apr 2014
Countries
1
Sponsor
Université Laval
Modality
Small Molecules
Conditions
secondary hyperparathyroidism (SHPT)
01

Overview

Phase 4, randomised, double-blind trial in secondary hyperparathyroidism (SHPT) comparing Cinacalcet Sequence with Placebo Sequence (2 arms). Primary endpoint: Carotid-Femoral Pulse Wave Velocity at 1 week. Started May 2012; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Cinacalcet Sequence

    Cinacalcet 30mg/d for 7 days followed by Placebo for 7 days

  • Placebo Sequence

    Placebo for 7 days followed by Cinacalcet 30mg/d for 7 days

03

Endpoints

Primary

  • Carotid-Femoral Pulse Wave Velocity

Secondary

  • Carotid-Radial Pulse Wave Velocity

  • Common Carotid Artery Biomechanics

  • Pulse Wave Profile

  • Ventricular Function

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