Primary HyperparathyroidismPhase 2NCT03774771
Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism
A Phase 2 study testing Cinacalcet in people with Primary Hyperparathyroidism, run by Amgen.
Trial summary
The primary objective was to assess the safety and tolerability of cinacalcet in adults with primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6 consecutive weeks and twice daily for 15 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Cinacalcet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 1998to 13 Dec 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age at screening. In Part 1, females must be postmenopausal (at least 12 months since last menstrual period) or surgically sterile.
- In Part 2, all qualified females replacing a Part 1 subject (i.e., naïve subjects), regardless of reproductive status, may participate if, in the opinion of the principal investigator, an appropriate effective contraceptive method is used throughout the study. All females must have a negative serum pregnancy test within 28 days prior to Baseline (Parts 1 and 2).
- Men and women participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. All females who are pregnant or breast-feeding are excluded. All subjects must notify the principal investigator if they or their partner suspects a pregnancy.
- Diagnosis of primary HPT. A plasma intact PTH concentration ≥ 45 pg/mL on at least two occasions at least 1 week apart during the 12 months prior to baseline (at least one of these determinations should be made during screening), and a corrected total serum calcium concentration (for each 1 g/dL decrease in albumin level below 4.0 g/dL, the calcium value should be increased by 0.8 mg/dL) greater than the upper limit of normal, but no greater than 12.5 mg/dL.
- 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 aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 2 times the upper limit of normal.
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- Fasting (8 hours) serum glucose ≤ 130 mg/dL and hemoglobin Alc within the central laboratory's normal range.
- Hematology panel, serum clinical chemistry and urinalysis results within normal ranges
- Chest x-ray without evidence of active, infectious, inflammatory or malignant process.
Who cannot join
- Any unstable medical condition, defined as having been hospitalized within 28 at prior to baseline, or otherwise unstable in the judgement of the investigator.
- Received within 21 day prior to baseline, therapy with systemic glucocorticoids, lithium, tricyclic antidepressants, thioridazine, haloperidol, flecainide, or other drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (e.g. thiazide or loop diuretics), and drugs that affect bone metabolism (e.g. calcitonin, selective estrogen receptor modulators [SERMs])
- Received, within 90 days prior to Baseline, chronic therapy with bisphosphonates or fluoride.
- Known alcohol abuse, or use of illicit drugs, within 12 months prior to Baseline
- Experienced a myocardial infarction (MI) within 6 months prior to Baseline
- A ventricular rhythm disturbance requiring current treatment
Show all 17Show fewer
- Received investigational drugs within 28 days prior to Baseline
- A history of seizures within 12 months prior to Baseline
- A history (within 5 years) of malignancy of any type, other than nonmelanomatous skin cancers or in situ cervical cancer
- A gastrointestinal disorder that may be associated with impaired absorption of orally administered medications
- A Body Mass Index (BMI) < 15 or > 40, obtained during screening
- An inability to swallow capsules
- Sarcoidosis, tuberculosis, or other diseases known to cause hypercalcemia
- Fasting spot urine calcium/creatinine ratio (mg) < 0.05
- A 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 (eg, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent.
- For Part 2, a subject from Part 1 who discontinued treatment early
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-week Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Clinical Effects of an Oral Calcimimetic Agent (AMG 073) in Primary Hyperparathyroidism
The primary objective was to assess the safety and tolerability of cinacalcet in adults with primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6 consecutive weeks and twice daily for 15 consecutive days.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Cinacalcet, Placebo
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called AMG 073, Sensipar®, Mimpara®
Capsule for oral administration
PlaceboDrug
Capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In Part 1 participants received placebo capsules orally once a day for 6 weeks. In Part 2 participants received placebo capsules twice a day for 15 days. Receives: Drug: Placebo |
| Cinacalcet 50 mg QD | Experimental | In Part 1 participants received 50 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 30 mg cinacalcet capsules twice a day for 15 days. Receives: Drug: Cinacalcet |
| Cinacalcet 75 mg QD | Experimental | In Part 1 participants received 75 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 40 mg cinacalcet capsules twice a day for 15 days. Receives: Drug: Cinacalcet |
| Cinacelcet 100 mg QD | Experimental | In Part 1 participants received 100 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 50 mg cinacalcet capsules twice a day for 15 days. Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events in Part 1 and Part 2
Measured: 6 weeks in Part 1 and 15 days in Part 2
Secondary outcomes (34)
Percent Change from Baseline in Serum Calcium Concentration
Measured: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
Area Under the Serum Calcium Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Area Under the Serum Calcium Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Minimum Serum Calcium Concentration in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Minimum Serum Calcium Concentration in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time When Serum Calcium was Below Baseline During the 24-hour Dosing Interval in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time When Serum Calcium was Below Baseline During the 12-hour Dosing Interval in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Percent Change from Baseline in Plasma Intact parathyroid Hormone (iPTH) Concentration
Measured: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
Area Under the Plasma iPTH Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Area Under the Plasma iPTH Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Minimum iPTH Concentration in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Minimum iPTH Concentration in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Time of Minimum iPTH Concentration in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Time of Minimum iPTH Concentration in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time When iPTH was Below Baseline During the 24-hour Dosing Interval in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time When iPTH was Below Baseline During the 12-hour Dosing Interval in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time iPTH was Below 45 pg/mL in Part 1
Measured: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time iPTH was Below 45 pg/mL in Part 2
Measured: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Percent Change from Baseline in Serum Calcitonin Concentration
Measured: Baseline and days 8, 15, and 43 in Part 1
Percentage of Participants with Serum Calcitonin Concentration Less than 10 pg/mL
Measured: Baseline and days 8, 15 and 43 in Part 1
Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP) Concentration
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with BALP Concentration Within Normal Range
Normal range of BALP is 2.9 to 20.1 ng/mL for men 20 to 79 years of age and and 3.7 to 20.9 ng/mL for women 20 to 79 years of age.
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in Serum N-telopeptide (NTx) Concentration
Measured: Baseline and days 8 and 15 in Part 1
Percentage of Participants with Serum NTx Concentration Within Normal Range
Normal range of serum NTx is 5.4 to 24.2 nmoL bone collagen equivalents (BCE)/L for men, 6.2 to 19.0 nmoL BCE/L for premenopausal women, and 5.3 to 35.8 nmol BCE/L for postmenopausal women (≥ 55 years).
Measured: Baseline and days 8 and 15 in Part 1
Percent Change from Baseline in Urinary NTx Concentration
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with Urinary NTx Concentration Within Normal Range
Normal range of urinary NTx is is 0.0 to 85.0 nmoL BCE/mmoL creatinine for men, 5.0 to 65.0 nmoL BCE/mmoL creatinine for premenopausal women, and 0.0 to 130.0 nmoL BCE/mmoL creatinine for postmenopausal women [≥ 55 years).
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in Urinary Calcium/Creatinine Ratio
Measured: Baseline and days 8 and 15 in Part 1
Percent Change from Baseline in Urinary Calcium Concentration
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with Urinary Calcium Concentration Within Normal Range
Normal range of urinary calcium is 50 to 300 mg/24 hours.
Measured: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in 1,25-Dihydroxy Vitamin D
Measured: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
Percentage of Participants with 1,25-Dihydroxy Vitamin D Concentration in the Normal Range
The normal range for 1,25-dihydroxy vitamin D3 is 16.0 to 65.0 pg/mL.
Measured: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
Percent Change from Baseline in Urinary and Serum Phosphorus Concentrations
Measured: Baseline and days 8, 15, and 22 in Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start29 Sep 1998
- Primary completion13 Dec 1999
- Study completion13 Dec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774771
- Sponsor's protocol ID
- 00980125
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 6-week Dose-Ranging Study to Assess the Safety, Pharmacokinetics, and Clinical Effects of an Oral Calcimimetic Agent (AMG 073) in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03774771
- Acronym / sponsor ID
- 00980125
- Conditions
- Primary Hyperparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 1998 (actual)
- Primary completion
- 13 Dec 1999 (actual)
- Study completion
- 13 Dec 1999 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to assess the safety and tolerability of cinacalcet in adults with primary hyperparathyroidism (HPT) when administered as a single oral once daily doses for 6 consecutive weeks and twice daily for 15 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIn Part 1 participants received placebo capsules orally once a day for 6 weeks. In Part 2 participants received placebo capsules twice a day for 15 days. |
| Cinacalcet 50 mg QD | Experimental | Drug: CinacalcetIn Part 1 participants received 50 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 30 mg cinacalcet capsules twice a day for 15 days. |
| Cinacalcet 75 mg QD | Experimental | Drug: CinacalcetIn Part 1 participants received 75 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 40 mg cinacalcet capsules twice a day for 15 days. |
| Cinacelcet 100 mg QD | Experimental | Drug: CinacalcetIn Part 1 participants received 100 mg cinacalcet capsules orally once a day (QD) for 6 weeks. In Part 2 participants received 50 mg cinacalcet capsules twice a day for 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females ≥ 18 years of age at screening. In Part 1, females must be postmenopausal (at least 12 months since last menstrual period) or surgically sterile.
- In Part 2, all qualified females replacing a Part 1 subject (i.e., naïve subjects), regardless of reproductive status, may participate if, in the opinion of the principal investigator, an appropriate effective contraceptive method is used throughout the study. All females must have a negative serum pregnancy test within 28 days prior to Baseline (Parts 1 and 2).
- Men and women participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. All females who are pregnant or breast-feeding are excluded. All subjects must notify the principal investigator if they or their partner suspects a pregnancy.
- Diagnosis of primary HPT. A plasma intact PTH concentration ≥ 45 pg/mL on at least two occasions at least 1 week apart during the 12 months prior to baseline (at least one of these determinations should be made during screening), and a corrected total serum calcium concentration (for each 1 g/dL decrease in albumin level below 4.0 g/dL, the calcium value should be increased by 0.8 mg/dL) greater than the upper limit of normal, but no greater than 12.5 mg/dL.
- Acceptable renal function, with an estimated creatinine clearance > 50 ml/min as determined by the Cockroft and Gault equation.
Key exclusion criteria (17 listed)
- Any unstable medical condition, defined as having been hospitalized within 28 at prior to baseline, or otherwise unstable in the judgement of the investigator.
- Received within 21 day prior to baseline, therapy with systemic glucocorticoids, lithium, tricyclic antidepressants, thioridazine, haloperidol, flecainide, or other drugs with a narrow therapeutic index that are primarily metabolized by hepatic cytochrome P450 CYP 2D6, drugs that affect renal tubular calcium handling (e.g. thiazide or loop diuretics), and drugs that affect bone metabolism (e.g. calcitonin, selective estrogen receptor modulators [SERMs])
- Received, within 90 days prior to Baseline, chronic therapy with bisphosphonates or fluoride.
- Known alcohol abuse, or use of illicit drugs, within 12 months prior to Baseline
- Experienced a myocardial infarction (MI) within 6 months prior to Baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinacalcetAlso: AMG 073, Sensipar®, Mimpara®Capsule for oral administration | Drug | Cinacalcet 50 mg QD, Cinacalcet 75 mg QD, Cinacelcet 100 mg QD |
| PlaceboCapsules for oral administration | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events in Part 1 and Part 2
Time frame: 6 weeks in Part 1 and 15 days in Part 2
34 secondary outcomes
Percent Change from Baseline in Serum Calcium Concentration
Time frame: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
Area Under the Serum Calcium Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Area Under the Serum Calcium Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Minimum Serum Calcium Concentration in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Minimum Serum Calcium Concentration in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time When Serum Calcium was Below Baseline During the 24-hour Dosing Interval in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time When Serum Calcium was Below Baseline During the 12-hour Dosing Interval in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time Over the Day When Serum Calcium was ≤ 10.3 mg/dL In Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Percent Change from Baseline in Plasma Intact parathyroid Hormone (iPTH) Concentration
Time frame: Baseline and days 8, 15, 16, 29, 43, and 50 in Part 1 and days 1, 8, 15, and 22 in Part 2.
Area Under the Plasma iPTH Concentration-time Curve from 0 to 24 Hours After Dosing (AUC0-24) in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Area Under the Plasma iPTH Concentration-time Curve from 0 to 12 Hours After Dosing (AUC0-12) in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Minimum iPTH Concentration in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Minimum iPTH Concentration in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Time of Minimum iPTH Concentration in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours postdose
Time of Minimum iPTH Concentration in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time When iPTH was Below Baseline During the 24-hour Dosing Interval in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time When iPTH was Below Baseline During the 12-hour Dosing Interval in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Cumulative Time iPTH was Below 45 pg/mL in Part 1
Time frame: Days 1, 8, and 43: Predose, 1, 2, 4, 8, 12, and 24 hours post dose
Cumulative Time iPTH was Below 45 pg/mL in Part 2
Time frame: Days 1 and 15: Predose, 1, 2, 4, 8, 12, 13, 14, 16, 20, and 24 hours postdose
Percent Change from Baseline in Serum Calcitonin Concentration
Time frame: Baseline and days 8, 15, and 43 in Part 1
Percentage of Participants with Serum Calcitonin Concentration Less than 10 pg/mL
Time frame: Baseline and days 8, 15 and 43 in Part 1
Percent Change from Baseline in Bone-specific Alkaline Phosphatase (BALP) Concentration
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with BALP Concentration Within Normal Range
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in Serum N-telopeptide (NTx) Concentration
Time frame: Baseline and days 8 and 15 in Part 1
Percentage of Participants with Serum NTx Concentration Within Normal Range
Time frame: Baseline and days 8 and 15 in Part 1
Percent Change from Baseline in Urinary NTx Concentration
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with Urinary NTx Concentration Within Normal Range
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in Urinary Calcium/Creatinine Ratio
Time frame: Baseline and days 8 and 15 in Part 1
Percent Change from Baseline in Urinary Calcium Concentration
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percentage of Participants with Urinary Calcium Concentration Within Normal Range
Time frame: Baseline and days 15 and 43 in Part 1 and days 1, 8, and 15 in Part 2
Percent Change from Baseline in 1,25-Dihydroxy Vitamin D
Time frame: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
Percentage of Participants with 1,25-Dihydroxy Vitamin D Concentration in the Normal Range
Time frame: Baseline and days 8 and 43 in Part 1 and days 1 and 15 in part 2
Percent Change from Baseline in Urinary and Serum Phosphorus Concentrations
Time frame: Baseline and days 8, 15, and 22 in Part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinacalcet in people with Primary Hyperparathyroidism, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events in Part 1 and Part 2 (time frame: 6 weeks in Part 1 and 15 days in Part 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.