Last reviewed · How we verify
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy
Phase 3 trial testing Cinacalcet in Hyperparathyroidism, Primary in 67 participants. Completed in 21 December 2012.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 10 March 2010 |
| Primary completion | 12 July 2012 |
| Estimated completion | 21 December 2012 |
| Sites | 47 locations across Russia, Poland, Hungary, Canada, Australia, Portugal, United States |
Amgen — full company profile →
18 and older, any sex, with Hyperparathyroidism, Primary or Hypercalcemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.0 | |
| Cinacalcet | 75.8 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 5.9 | |
| Cinacalcet | 84.8 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.66 | ± 0.99 |
| Cinacalcet | -15.21 | ± 1.00 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.01 | ± 4.05 |
| Cinacalcet | -23.80 | ± 4.18 |
Time frame: 60 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Double-blind Phase: Placebo | Double-blind Phase: Cinaca… | Open-label Phase: Previous… | Open-label Phase: Previous… |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | — | — | — | — |
| Hyperparathyroidism primary | Endocrine disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Rib fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — | — | — |
| Vertebrobasilar insufficiency | Nervous system disorders | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Aortic aneurysm | Vascular disorders | — | — | — | — |
| Reaction | System | Double-blind Phase: Placebo | Double-blind Phase: Cinaca… | Open-label Phase: Previous… | Open-label Phase: Previous… |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Muscle twitching | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Hypoaesthesia | Nervous system disorders | — | — | — | — |
| Tremor | Nervous system disorders | — | — | — | — |
| Renal pain | Renal and urinary disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
Most-reported serious reactions: Coronary artery occlusion, Hyperparathyroidism primary, Abdominal pain, Nausea, Vomiting, Cholelithiasis, Infective exacerbation of chronic obstructive airways disease, Urinary tract infection.
Data from ClinicalTrials.gov NCT00975221 adverse events section.
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00975221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing