- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776058
Safety, Tolerability, and Clinical Effects of Twice-daily Doses of Cinacalcet (AMG 073) in Adults With Primary Hyperparathyroidism (HPT)
December 13, 2018 updated by: Amgen
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Clinical Effects of Twice-daily Doses of an Oral Calcimimetic Agent (AMG 073) in Subjects With Primary Hyperparathyroidism (HPT)
The primary objectives were to assess the safety and tolerability of twice daily (BID) doses of 65 mg cinacalcet administered orally to adults with primary HPT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women ≥ 18 years old before beginning of screening
- Use, in the opinion of the principal investigator, effective contraceptive measures throughout the study
- Negative serum pregnancy test within 15 days before day 0
- Plasma iPTH concentration > 45 pg/mL on at least 2 occasions (during the screening phase) at least 7 days apart
- Serum calcium concentration ≥ 11 mg/dL on 2 occasions (during the screening phase) at least 7 days apart
- Acceptable renal function, with an estimated creatinine clearance > 50 mL/min as determined by the Cockroft and Gault equation
- Acceptable hepatic function, defined as serum aspartate transaminase (AST), alanine transaminase (ALT), and total bilirubin ≤ 2 times the upper limit of normal (central laboratory's range)
- Laboratory test results within the central laboratory's normal range for hematology, coagulation, urinalysis, and clinical chemistry parameters not mentioned specifically in other inclusion/exclusion criteria
- Chest x-ray within the past 12 months, with no evidence of an active infectious, inflammatory, or malignant process
- Informed consent for participation in the study
Exclusion Criteria:
- Any unstable medical condition requiring hospitalization within 30 days before day 0, or otherwise unstable condition in the judgment of the investigator
- Awaiting or scheduled for parathyroidectomy within 2 months after study day 0
- Pregnant or nursing
- Received, within 21 days before day 0, therapy with systemic glucocorticoids (> 5 mg/day prednisone or equivalent), lithium, tricyclic antidepressants (with the exception of amitriptyline and nortriptyline), thioridazine, haloperidol, flecainide, drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (ie, thiazide or loop diuretics), or calcitonin
- Dose changes in bisphosphonates, thyroid replacement therapy, selective estrogen receptor modulators (SERMs), or changes in daily doses of estrogen (greater than 0.75 mg) within 90 days before day 0
- Subjects who discontinued estrogen or SERM therapy must have been off treatment for at least 90 days before day 0.
- Alcohol or illicit drug abuse within 12 months before day 0 based on self-report
- Myocardial infarction within 6 months before day 0
- Ventricular rhythm disturbance requiring current treatment
- Seizure within 12 months before day 0
- History (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer
- Evidence (within 5 years) of treatment for and/or active sarcoidosis, tuberculosis, or diseases other than primary HPT known to cause hypercalcemia
- History of familial hypocalciuric hypercalcemia (FHH)
- Uncontrolled diabetes, as defined by hemoglobin A1c (HbA1c) ≥ 8.0
- Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications
- Inability to swallow tablets similar in size to an aspirin tablet
- Known sensitivity to products administered during the study
- Previous participation as a subject in this study (ie, withdrawn early) or a prior study involving AMG 073 administration
- Enrolled in, or not yet completed at least 28 days since ending other investigational device or drug trial(s)
- Psychiatric disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
- Any other condition that might reduce the chance of obtaining data (ie, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cinacalcet
Participants received 65 mg cinacalcet orally twice a day for 4 weeks.
|
Tablets for oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Participants received placebo to cinacalcet orally twice a day for 4 weeks.
|
Tablets for oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events
Time Frame: 4 weeks
|
4 weeks
|
Number of Participants with Clinically Significant Laboratory Tests, Vital Signs or Electrocardiogram Assessments
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent Change from Baseline in Serum Calcium
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Plasma Intact Parathyroid Hormone (iPTH)
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP)
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in 1,25 dihydroxy Vitamin D3
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Serum Phosphorus
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in N-telopeptide (NTx)
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Urine Osmolality
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Calcium/Creatinine Ratio
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in Phosphorus/Creatinine Ratio
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Percent Change from Baseline in N-telopeptide/Creatinine Ratio
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 15, 2000
Primary Completion (ACTUAL)
December 26, 2000
Study Completion (ACTUAL)
December 26, 2000
Study Registration Dates
First Submitted
December 13, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (ACTUAL)
December 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 14, 2018
Last Update Submitted That Met QC Criteria
December 13, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00990160
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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