- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07917039
A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2072 Tablets in Chinese Participants With Primary Aldosteronism
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to explore the efficacy and safety of SYH2072 tablets in Chinese participants with primary aldosteronism (PA) .
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Participants diagnosed with primary aldosteronism will be randomly assigned to the SYH2072 group or the placebo group for a double-blind treatment period. SYH2072 (or matching placebo) will be administered once daily, with the dose up-titrated during the treatment period based on clinical response and tolerability.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Clinical Trials Information Group NA officer
- Telefonnummer: 86-311-69085587
- E-post: ctr-contact@cspc.cn
Studieorter
-
-
Shandong
-
Jinan, Shandong, Kina, 250000
- Qilu Hospital of Shandong University
-
Kontakt:
- Telefonnummer: 86-531-82169603
- E-post: qlyygcp_ec@qiluhospital.cn
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Aged 18 years or older; male or female.
- Documented diagnosis of primary aldosteronism (PA) before screening.
- Receiving stable antihypertensive therapy.
- Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
- Mean seated office systolic blood pressure (SBP) ≥140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg before randomization.
- Medication compliance of background antihypertensive therapy and placebo within 80%-120% during the run-in period.
- Voluntary participation in the study, with signed informed consent form.
Exclusion Criteria:
- Night shift workers.
- Known secondary causes of hypertension other than PA.
- Hypotension.
- Known hypersensitivity or allergic constitution.
- History of adrenal surgery, renal denervation, or similar procedures.
- History of adrenal insufficiency.
- Poorly controlled blood glucose, or GLP-1 receptor agonist not maintained at a stable dose for at least 4 weeks.
- Poorly controlled thyroid disease.
- Severe cardiovascular or cerebrovascular events within 6 months before screening.
- Severe arrhythmia within 6 months before screening.
- Severe heart failure within 6 months before screening.
- Major surgery within 6 months before screening.
- Severe gastrointestinal disease or history of gastrointestinal surgery.
- Clinically significant laboratory abnormalities.
- History of malignancy within 5 years.
- History of drug abuse within 5 years.
- Female participants who are pregnant, breastfeeding, or with a positive pregnancy test.
- Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within 4 weeks before screening.
- Participation in any drug or device clinical trial within 3 months before screening.
- Regular alcohol consumption within 90 days before screening.
- Any other reason that, in the opinion of the investigator, may prevent the participant from completing the study, or any condition for which the investigator considers enrollment inappropriate.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo group
Placebo |
Placebo administered orally, once daily (QD). |
|
Experimentell: SYH2072 group
SYH2072 Tablets |
SYH2072 tablets administered orally, once daily (QD) Placebo administered orally, once daily (QD). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
Tidsram: week 8
|
To evaluate the efficacy of SYH2072 tablets in improving blood pressure in trial participants with primary aldosteronism (PA) in China. |
week 8
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Yuguo Chen, Medical Doctor, Qilu Hospital of Shandong University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SYH2072-004
Läkemedels- och apparatinformation, studiedokument
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