A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2005-12-31

Brief Summary

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

This multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study consisted of 2 consecutive phases that occurred in the following order: a dose-titration phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.

Related Clinical Trials

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

A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

NCT00936650

Hyperparathyroidism, Primary

COMPLETED PHASE2

Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism

NCT03774771

Primary Hyperparathyroidism

COMPLETED PHASE2

Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)

NCT03776058

Primary Hyperparathyroidism

COMPLETED PHASE2

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

NCT00975221

Hyperparathyroidism, Primary Hypercalcemia

COMPLETED PHASE3

Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

NCT00975000

Chronic Allograft Nephropathy Chronic Kidney Disease Chronic Renal Failure +7 more

COMPLETED PHASE3

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.

Hyperparathyroidism, Primary

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

cinacalcet

Group Type EXPERIMENTAL

cinacalcet

Intervention Type DRUG

Subjects began open-label treatment with 30 mg cinacalcet twice daily (BID) at the start of the current study. The study consisted of 2 phases planned to total approximately 4¾ years: a 12-week dosetitration phase (visits at weeks 2, 3, 4, 6, 9, and 12) during which 1 possible dose increase of cinacalcet from 30 mg BID to 50 mg BID could occur at week 6, and a maintenance phase (week 12 to 234; visits approximately every 4 weeks until week 24 and approximately every 14 weeks thereafter) during which doses also could be titrated. After July 2004, because of a change in dose strengths, the daily doses used in the study were 30 and 60 mg BID with the option to reduce to 30 mg once daily (QD), if necessary. Ongoing subjects receiving 50 mg BID were switched at that time to 60 mg BID.

Interventions

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

cinacalcet

Subjects began open-label treatment with 30 mg cinacalcet twice daily (BID) at the start of the current study. The study consisted of 2 phases planned to total approximately 4¾ years: a 12-week dosetitration phase (visits at weeks 2, 3, 4, 6, 9, and 12) during which 1 possible dose increase of cinacalcet from 30 mg BID to 50 mg BID could occur at week 6, and a maintenance phase (week 12 to 234; visits approximately every 4 weeks until week 24 and approximately every 14 weeks thereafter) during which doses also could be titrated. After July 2004, because of a change in dose strengths, the daily doses used in the study were 30 and 60 mg BID with the option to reduce to 30 mg once daily (QD), if necessary. Ongoing subjects receiving 50 mg BID were switched at that time to 60 mg BID.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Successfully completed the parent study 990120
* Agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study
* Were able to comprehend and were willing to give written informed consent for participation in the study

Exclusion Criteria

* Pregnant or breast-feeding
* Had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements
* Had any other condition that reduced the chance of obtaining data (eg, known poor compliance)
* Participating in another investigational study at the time of study entry
* Had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No