Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis

NCT00094484

Kidney Disease Chronic Kidney Disease

COMPLETED PHASE3

A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis

NCT00042653

Secondary Hyperparathyroidism End Stage Renal Disease

COMPLETED PHASE3

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

NCT00117052

Secondary Hyperparathyroidism End Stage Renal Disease

COMPLETED PHASE3

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

NCT01181531

Hyperparathyroidism, Secondary

COMPLETED PHASE4

Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

NCT00446329

Secondary Hyperparathyroidism

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Hyperparathyroidism Chronic Renal Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cinacalcet (AMG 073)

Group Type EXPERIMENTAL

cinacalcet (AMG 073)

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

cinacalcet (AMG 073)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cinacalcet (AMG 073)

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.

Intervention Type DRUG