A Study to Evaluate Efficacy and Safety of GW906 Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of GW906 Injection (SAL0132) Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications
The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906 as add-on therapy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection used as add-on therapy in patients with hypertension not adequately controlled by one or two antihypertensive medications.
Participants are randomized to receive either GW906 Injection or placebo for 6 months.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Jianan Wang, Professor
- Telefonnummer: 86-1599008651
- E-post: jiguangwang@rjh.com.cn
Studiesteder
-
-
Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
-
Ta kontakt med:
- Jianan Wang, Professor
- Telefonnummer: 86-15990086511
- E-post: jiguangwang@rjh.com.cn
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years, of either sex.
- Treated hypertension on stable therapy with up to 1 or 2 antihypertensive medications. Stable therapy is defined as having no change in antihypertensive medication or dose within 4 weeks prior to randomization.
- Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at the randomization visit.
- Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
- Secondary hypertension.
- orthostatic hypotension.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; International normalized ratio (INR) > 2.0; Serum potassium > 5.0 mmol/L or < 3.5 mmol/L; eGFR≤30 mL/min/1.73m^2.
- Received an investigational agent within the last 3 months.
- Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus.
- History of any cardiovascular event within 12 months.
- History of intolerance to SC injection(s).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: GW906
Subcutaneous injection. 24 weeks |
Subcutaneous injection. 24 weeks |
|
Placebo komparator: Placebo
Subcutaneous injection. 24 weeks |
Subcutaneous injection. 24 weeks |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
Tidsramme: Baseline and Month 3
|
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg |
Baseline and Month 3
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
Tidsramme: Baseline, Weeks 4, 8, and 24
|
Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg |
Baseline, Weeks 4, 8, and 24
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SAL0132A202
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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