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Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Subjects With PHPT Unable to Undergo Parathyroidectomy

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperparathyroidism, Primary; Hypercalcemia

Intervention: cinacalcet HCl (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This phase 3, randomized, double-blind, placebo-controlled study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in subjects with primary HPT for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy. The reasons a subject would be unable to undergo parathyroidectomy include failed parathyroidectomy, medical contraindication to surgery, or because together with their primary physician they decided it was inappropriate. The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16 week placebo-controlled efficacy assessment phase (EAP). Subjects who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.

Clinical Details

Official title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: to demonstrate the efficacy of cinacalcet for normalizing serum calcium in subjects with primary HPT who are unable to undergo parathyroidectomy

Secondary outcome: to demonstrate the efficacy of cinacalcet for reducing corrected total serum calcium and plasma PTH levels

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age ≥18 years

- diagnosis of primary HPT

- subjects must have the following laboratory values:

1. local/historical laboratory result showing a corrected total serum calcium > 1 mg/dL (0. 25 mmol/L) above the upper limit of normal and ≤ 12. 5 mg/dL (3. 12 mmol/L) within the past 12 months, and

- local/historical laboratory result showing a plasma PTH > 75% of upper

limit of normal within the past 12 months, and

- one central laboratory draw at the screen visit showing a corrected total

serum calcium > 11. 3 mg/dL (2. 82 mmol/L) and ≤ 12. 5 mg/dL (3. 12 mmol/L), and

- one central laboratory draw at the screen visit showing a plasma PTH > 55

pg/mL (5. 8 pmol/L) OR 2. two central laboratory draws performed during the screening period at least 7 days apart, showing a

- corrected total serum calcium > 11. 3 mg/dL (2. 82 mmol/L) and ≤ 12. 5 mg/dL

(3. 12 mmol/L), and

- plasma PTH > 55 pg/mL (5. 8 pmol/L)

- not able to undergo parathyroidectomy for ≥ 1 of the following reasons:

- failed parathyroidectomy

- comorbid conditions contraindicating parathyroidectomy

- parathyroidectomy not considered appropriate or is not feasible by primary

physician and subject

- before any study-specific procedure is performed, the appropriate written informed

consent must be obtained Exclusion Criteria:

- symptoms attributable to hypercalcemia, requiring immediate medical intervention, as

judged by the investigator (including acute kidney stone, nausea and vomiting requiring intravenous hydration, confusion, lethargy, stupor, or coma)

- unstable medical condition, defined as having been hospitalized within 30 days before

the date of informed consent, or otherwise unstable in the judgment of the investigator

- administration of drugs that increase serum calcium concentration, including but not

limited to thiazide diuretics or lithium

- initiated bisphosphonate therapy or changed bisphosphonate dose within 12 weeks

before the date of informed consent

- current administration of drugs for ventricular arrhythmia

- unable to provide informed consent, or is at risk for poor compliance with study

procedures

- currently enrolled in another investigational device or drug study(s), or completed

such study within 30 days before the date of informed consent

- known hypersensitivity to or unable to tolerate cinacalcet

- received treatment with cinacalcet within 60 days before the date of informed consent

- history of seizures or an adjustment of anti-seizure medication within 12 weeks

before the date of informed consent

- family history or diagnosis a genetic syndrome, such as familial benign hypocalciuric

hypercalcemia (FBHH) or multiple endocrine neoplasia type 1 (MEN1) and type 2 (MEN2), where primary HPT is one of the clinical manifestations of familial benign hypocalciuric hypercalcemia (FBHH)

- refused to use highly effective contraceptive measures (as determined by the

investigator) throughout the study

- pregnant or breastfeeding

Locations and Contacts

Research Site, Budapest 1083, Hungary

Research Site, Budapest 1088, Hungary

Research Site, Budapest 1113, Hungary

Research Site, Szeged 6720, Hungary

Research Site, Warszawa 01-809, Poland

Research Site, Warszawa 02-097, Poland

Research Site, Warszawa 02-507, Poland

Research Site, Coimbra 3000-075, Portugal

Research Site, Lisboa 1350-179, Portugal

Research Site, Lisboa 1649-035, Portugal

Research Site, Moscow 117036, Russian Federation

Research Site, Moscow 119034, Russian Federation

Research Site, Moscow 129110, Russian Federation

Research Site, Rostov-na-Dony 344022, Russian Federation

Research Site, Saint Petersburg 197341, Russian Federation

Research Site, Yaroslavl 150003, Russian Federation

Research Site, Calgary, Alberta T2N 4Z6, Canada

Research Site, Lake Forest, California 92630, United States

Research Site, Lancaster, California 93534, United States

Research Site, Los Gatos, California 95032, United States

Research Site, Mission Viejo, California 92691, United States

Research Site, Orange, California 92869, United States

Research Site, San Diego, California 92124, United States

Research Site, Aurora, Colorado 80045, United States

Research Site, Washington, District of Columbia 20010, United States

Research Site, Aventura, Florida 33180, United States

Research Site, Clearwater, Florida 33756, United States

Research Site, Jacksonville, Florida 32204, United States

Research Site, Miami, Florida 33145, United States

Research Site, Pembroke Pines, Florida 33028, United States

Research Site, Weston, Florida 33331, United States

Research Site, Atlanta, Georgia 30322, United States

Research Site, Indianapolis, Indiana 46202, United States

Research Site, Kenner, Louisiana 70065, United States

Research Site, New Orleans, Louisiana 70121, United States

Research Site, Detroit, Michigan 48236, United States

Research Site, Randwick, New South Wales 2031, Australia

Research Site, St Leonards, New South Wales 2065, Australia

Research Site, New York, New York 10032, United States

Research Site, Morehead City, North Carolina 28557, United States

Research Site, Columbus, Ohio 43210-1296, United States

Research Site, London, Ontario N6A 4V2, Canada

Research Site, Oakville, Ontario L6J 1X8, Canada

Research Site, Toronto, Ontario M5C 2T2, Canada

Research Site, Footscray, Victoria 3011, Australia

Research Site, Geelong, Victoria 3220, Australia

Research Site, Nedlands, Western Australia 6009, Australia

Additional Information

AmgenTrials clinical trials website

Starting date: October 2009
Last updated: May 9, 2014

Page last updated: August 23, 2015

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