Trial · NCT04605549
A Study of CIN-107 in Adults With Primary Aldosteronism
NCT04605549, Phase 2, Completed, AstraZeneca; results first posted 2026-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CIN-107 in Adults With Primary Aldosteronism. Trials, record NCT04605549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04605549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CIN-107 in Adults With Primary Aldosteronism
- NCT number
- NCT04605549
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Primary Aldosteronism, Hyperaldosteronism
- Interventions
- CIN-107 2 mg dosing, CIN-107 4 mg dosing, CIN-107 8 mg dosing
- First posted
- 2020-10-28
- Last updated
- 2026-03-03
- Results first posted
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | 74 weeks | An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period. |
| Primary | Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism | 12 weeks | The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated. |
| Secondary | Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism | 12 weeks | The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated. |
| Secondary | The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg | 12 weeks | The percentage of patients achieving a mean seated SBP \<140 mmHg and a mean DBP of \<90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated. |
| Secondary | The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg | 12 weeks | The percentage of patients achieving a mean seated SBP \<130 mmHg and a mean DBP of \<80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated. |
| Secondary | The Percentage of Patients Achieving the Pharmacodynamic Marker Response | 12 weeks | Pharmacodynamic marker response is defined as achieving either: - a plasma aldosterone concentration (PAC) \< 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR \< 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events | 74 weeks | The Safety Population is defined as all enrolled patients who receive at least one dose of study drug. Due to the small sample size of the study, arms/groups are combined for analysis. | Number of events | NUMBER |
| PRIMARY | Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism | 12 weeks | ITT Population is defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism | 12 weeks | ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis. | mmHg | MEAN |
| SECONDARY | The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg | 12 weeks | ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg | 12 weeks | ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Percentage of Patients Achieving the Pharmacodynamic Marker Response | 12 weeks | ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events | CIN-107 | Part 1 before titration (0-Week 4) | 27 | Number of events | |
| Number of Treatment Emergent Adverse Events | CIN-107 | Part 1 after titration (Week 4-Week 12) | 34 | Number of events | |
| Number of Treatment Emergent Adverse Events | CIN-107 | Part 2 (Week 12-Week 74) | 101 | Number of events | |
| Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism | CIN-107 | -24.9 | Standard Deviation 11.6 | mmHg | |
| Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism | CIN-107 | -10.6 | Standard Deviation 8.95 | mmHg | |
| The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg | CIN-107 | 11 | Participants | ||
| The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg | CIN-107 | 6 | Participants | ||
| The Percentage of Patients Achieving the Pharmacodynamic Marker Response | CIN-107 | 12 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (0 to 12 Weeks) | STARTED | CIN-107 | 15 | |
| Part 1 (0 to 12 Weeks) | COMPLETED | CIN-107 | 15 | |
| Part 1 (0 to 12 Weeks) | NOT COMPLETED | CIN-107 | 0 | |
| Part 2 (12 to 74 Weeks) | STARTED | CIN-107 | 14 | |
| Part 2 (12 to 74 Weeks) | COMPLETED | CIN-107 | 12 | |
| Part 2 (12 to 74 Weeks) | NOT COMPLETED | CIN-107 | 2 |
Source ClinicalTrials.gov
Adverse events679
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 | Urinary tract infection | Infections and infestations | CIN-107 2 mg Part 1 - Before Titration | 1 | 15 | 1 |
| other | Urinary tract infection | Infections and infestations | CIN-107 2 mg Part 1 - After Titration | 0 | 3 | 0 |
| other | Urinary tract infection | Infections and infestations | CIN-107 4 mg Part 1 - After Titration | 0 | 13 | 0 |
| other | Urinary tract infection | Infections and infestations | CIN-107 8 mg Part 1 - After Titration | 0 | 8 | 0 |
| other | Urinary tract infection | Infections and infestations | CIN-107 2 mg Part 2 | 0 | 4 | 0 |
| other | Urinary tract infection | Infections and infestations | CIN-107 4 mg Part 2 | 0 | 7 | 0 |
| other | Urinary tract infection | Infections and infestations | CIN-107 8 mg Part 2 | 0 | 7 | 0 |
| other | Constipation | Gastrointestinal disorders | CIN-107 2 mg Part 1 - Before Titration | 0 | 15 | 0 |
| other | Constipation | Gastrointestinal disorders | CIN-107 2 mg Part 1 - After Titration | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | CIN-107 4 mg Part 1 - After Titration | 1 | 13 | 1 |
1 to 10 of 679Source ClinicalTrials.gov
See all 679 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CIN-107 2 mg Part 1 - Before Titration | 0 | 15 |
| Total, all-cause mortality | CIN-107 2 mg Part 1 - After Titration | 0 | 3 |
| Total, all-cause mortality | CIN-107 4 mg Part 1 - After Titration | 0 | 13 |
| Total, all-cause mortality | CIN-107 8 mg Part 1 - After Titration | 0 | 8 |
| Total, all-cause mortality | CIN-107 2 mg Part 2 | 0 | 4 |
| Total, all-cause mortality | CIN-107 4 mg Part 2 | 0 | 7 |
| Total, all-cause mortality | CIN-107 8 mg Part 2 | 0 | 7 |
| Total, other adverse events | CIN-107 2 mg Part 1 - Before Titration | 11 | 15 |
| Total, other adverse events | CIN-107 2 mg Part 1 - After Titration | 1 | 3 |
| Total, other adverse events | CIN-107 4 mg Part 1 - After Titration | 8 | 13 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37490693 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04605549
GET https://conductscience.org/api/trials/v1/NCT04605549/events?page=2