CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
cinacalcet (AMG 073)drug
Likely dose
Cinacalcet 30-180 mg orally once daily with titration over 12 weeksAI-extracted
Key inclusion· 3
  • ✓Chronic renal insufficiency (pre-dialysis stage)
  • ✓Reduced creatinine clearance
  • ✓Elevated parathyroid hormone levels
Key exclusion· 2
  • ✕Myocardial infarction within 3 months
  • ✕Pregnancy or nursing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00042432
NCT00042432Phase 2Completed
CompareCT.gov

A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Amgen·interventional·Posted Aug 1, 2002·Updated May 13, 2013

In Brief

A Phase 2 clinical trial evaluating cinacalcet (AMG 073) for Secondary Hyperparathyroidism and Chronic Renal Insufficiency. Completed, enrolled 54 participants.

Detailed Summary

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Chronic Renal Insufficiency
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2002
Enrollment StartJun 1, 2002
Primary CompletionMar 1, 2003
Study CompletionAug 1, 2003
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 23.9 years ago

Interventions

cinacalcet (AMG 073)drug

Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.