Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00094484 |
Recruitment Status :
Completed
First Posted : October 20, 2004
Last Update Posted : May 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Disease Chronic Kidney Disease | Drug: Cinacalcet HCl | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis |
Study Start Date : | October 2004 |

- Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
- Changes in iPTH at 32 weeks.
- Safety and tolerability of cinacalcet at 32 weeks.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094484
Study Director: | MD | Amgen |
Publications of Results:
Responsible Party: | Global Development Leader, Amgen Inc. |
ClinicalTrials.gov Identifier: | NCT00094484 |
Other Study ID Numbers: |
20000178 |
First Posted: | October 20, 2004 Key Record Dates |
Last Update Posted: | May 8, 2013 |
Last Verified: | May 2013 |
Sensipar® Mimpara® Cinacalcet Calcimimetic Chronic Kidney Disease |
Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Renal Insufficiency Parathyroid Diseases |
Endocrine System Diseases Cinacalcet Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |