Trial · NCT00345839
E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
NCT00345839, Phase 3, Completed, Amgen; results first posted 2014-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events. Trials, record NCT00345839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345839
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
- NCT number
- NCT00345839
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,883 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Cinacalcet, Placebo
- First posted
- 2006-06-29
- Last updated
- 2022-11-07
- Results first posted
- 2014-01-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) | From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years | Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country. |
| Secondary | Time to All-cause Mortality | From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years | Time to All-cause Mortality. Stratified by history of diabetes and country. |
| Secondary | Time to Myocardial Infarction | From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years | Time to Myocardial Infarction. Stratified by history of diabetes and country. |
| Secondary | Time to Hospitalization for Unstable Angina | From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years | Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country. |
| Secondary | Time to Heart Failure | From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years | Time to Heart Failure. Stratified by history of diabetes and country. |
| Secondary | Time to Peripheral Vascular Event | From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years | Time to Peripheral Vascular Event. Stratified by history of diabetes and country. |
| Secondary | Time to Cardiovascular Mortality | From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years | Time to Cardiovascular Mortality. Stratified by history of diabetes and country. |
| Secondary | Time to Stroke | From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years | Time to Stroke. Stratified by history of diabetes and country. |
| Secondary | Time to Bone Fracture | From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years | Time to Bone Fracture. Stratified by history of diabetes and country. |
| Secondary | Time to Parathyroidectomy | From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years | Time to Parathyroidectomy. Stratified by history of diabetes and country. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) | From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to All-cause Mortality | From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Myocardial Infarction | From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Hospitalization for Unstable Angina | From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Heart Failure | From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Peripheral Vascular Event | From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Cardiovascular Mortality | From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Stroke | From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Bone Fracture | From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
| SECONDARY | Time to Parathyroidectomy | From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years | Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) | Cinacalcet | 55.0 | Inter-Quartile Range 22.6 to NA | Months | |
| Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) | Placebo | 53.0 | Inter-Quartile Range 19.1 to NA | Months | |
| Time to All-cause Mortality | Cinacalcet | NA | Inter-Quartile Range 37.9 to NA | Months | |
| Time to All-cause Mortality | Placebo | NA | Inter-Quartile Range 31.6 to NA | Months | |
| Time to Myocardial Infarction | Cinacalcet | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Myocardial Infarction | Placebo | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Hospitalization for Unstable Angina | Cinacalcet | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Hospitalization for Unstable Angina | Placebo | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Heart Failure | Cinacalcet | NA | Inter-Quartile Range NA to NA | Months | |
| Time to Heart Failure | Placebo | NA | Inter-Quartile Range NA to NA | Months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 1,948 | |
| Overall Study | STARTED | Placebo | 1,935 | |
| Overall Study | COMPLETED | Cinacalcet | 1,799 | |
| Overall Study | COMPLETED | Placebo | 1,776 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 149 | |
| Overall Study | NOT COMPLETED | Placebo | 159 |
Source ClinicalTrials.gov
Adverse events2,628
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 96 | 1,923 | |
| other | Anaemia | Blood and lymphatic system disorders | Cinacalcet | 109 | 1,938 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 154 | 1,923 | |
| other | Abdominal pain | Gastrointestinal disorders | Cinacalcet | 187 | 1,938 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 121 | 1,923 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cinacalcet | 153 | 1,938 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 349 | 1,923 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 376 | 1,938 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 89 | 1,923 | |
| other | Dyspepsia | Gastrointestinal disorders | Cinacalcet | 140 | 1,938 |
1 to 10 of 2,628Source ClinicalTrials.gov
See all 2,628 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Cinacalcet | ||
| Total, other adverse events | Placebo | 1,220 | 1,923 |
| Total, other adverse events | Cinacalcet | 1,444 | 1,938 |
| Total, serious adverse events | Placebo | 1,351 | 1,923 |
| Total, serious adverse events | Cinacalcet | 1,338 | 1,938 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cinacalcet vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00345839
GET https://conductscience.org/api/trials/v1/NCT00345839/events?page=2