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The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.
A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg DP13 daily | Experimental | DP13 for 8 weeks |
|
| 8 mg DP13 daily | Experimental | DP13 for 8 weeks |
|
| 12 mg DP13 daily | Experimental | DP13 for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexfadrostat phosphate | Drug | DP13 systemic administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aldosterone-to-renin Ratio | Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group. | 8 weeks |
| Change in Ambulatory Systolic Blood Pressure | All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Potassium | Change from baseline after 8 weeks of treatment with dexfadrostat phosphate | 8 weeks |
| Change in Ambulatory Diastolic Blood Pressure | Change from baseline following 8-weeks of dexfadrostat phosphate treatment |
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Inclusion Criteria:
Patients with a guideline-recommended diagnosis of primary aldosteronism
Exclusion Criteria:
Patients with primary aldosteronism and
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Mulatero, Prof | University of Torino, Torino, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Molinette | Torino | 10126 | Italy |
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Patient screening ARR and BP were reviewed and approved by the Eligibility Review Panel prior to study enrollment.
A suppression test was required prior to study entry to confirm PA diagnosis. Patients had a 2-week placebo run-in prior to randomization.
Patients were recruited 'de novo' i.e., diagnosed with Primary Aldosteronism within 10 weeks of study entry or as 'recently diagnosed' i.e., diagnosed between 10 weeks and 1 year prior to study entry
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg DP13 | Patients receiving the low dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast |
| FG001 | 8 mg DP13 | Patients receiving the middle dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast |
| FG002 | 12 mg DP13 | Patients receiving the high dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg DP13 | Baseline values were determined following 2 weeks of single-blind placebo run-in |
| BG001 | 8 mg DP13 | Baseline values were determined following 2 weeks of single-blind placebo run-in |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Aldosterone-to-renin Ratio | Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group. | Posted | Median | Inter-Quartile Range | ng*L/dL*mU | 8 weeks |
|
Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate
All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 mg DP13 | Patients receiving low dose dexfadrostat phosphate daily for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amylase increase | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Gerlock/Chief Operations Officer | DAMIAN Pharma AG | +41 79 230 8591 | teresa.gerlock@damianpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2020 | Dec 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| 8 weeks |
| Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA) | Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate | 8 weeks |
| BG002 | 12 mg DP13 | Baseline values were determined following 2 weeks of single-blind placebo run-in |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Office systolic blood pressure (oSBP) | Mean | Standard Deviation | mmHg |
|
| Office diastolic blood pressure (oDBP) | Mean | Standard Deviation | mmHg |
|
| Aldosterone-to-renin ratio (ARR) | Median | Inter-Quartile Range | ng*L/dL*mU |
|
| 24-hour ambulatory systolic blood pressure (aSBP) | Mean | Standard Deviation | mmHg |
|
| 24-hour ambulatory diastolic blood pressure (aDBP) | Mean | Standard Deviation | mmHg |
|
| Potassium | Mean | Standard Deviation | mmol/L |
|
| 24-hour Urinary Tetrahydroaldosterone Content (uTHA) | Median | Inter-Quartile Range | ug/24h |
|
| OG003 | All Dose Arms Combined | Values are after 8 weeks of treatment with dexfadrostat phosphate |
|
|
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| Primary | Change in Ambulatory Systolic Blood Pressure | All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined. | Posted | Mean | Standard Deviation | mm Hg | 8 weeks |
|
|
|
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| Secondary | Change in Potassium | Change from baseline after 8 weeks of treatment with dexfadrostat phosphate | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
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| Secondary | Change in Ambulatory Diastolic Blood Pressure | Change from baseline following 8-weeks of dexfadrostat phosphate treatment | Posted | Mean | Standard Deviation | mm Hg | 8 weeks |
|
|
|
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| Secondary | Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA) | Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate | Posted | Median | Inter-Quartile Range | ug/24 hour urine | 8 weeks |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 8 mg DP13 | Patients receiving middle dose dexfadrostat phosphate daily for 8 weeks | 0 | 12 | 0 | 12 | 6 | 12 |
| EG002 | 12 mg DP13 | Patients receiving high dose dexfadrostat phosphate daily for 8 weeks | 0 | 13 | 0 | 13 | 7 | 13 |
| Blood lactate dehydrogenase increase | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Blood pressure diastolic increase | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Duodenitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Amenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment | Dyspnea during exercise |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Lower limb edema | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastric leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
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