Mild-to-moderate Essential HypertensionPhase 3NCT06771245
A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients
A Phase 3 study testing SYH9056, Levamlodipine and Valsartan in people with Mild-to-moderate Essential Hypertension, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild-to-moderate Essential Hypertension
- What is being tested?
- SYH9056, Levamlodipine and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- No sites listed yet
- Study dates
- 24 Jan 2025to 30 Oct 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 (inclusive) years old;
- 18.0 kg/m^2 ≤ BMI ≤ 35.0 kg/m^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;
- Diagnosis of mild or moderate essential hypertension;
- Office blood pressure measurements meet any of the following at the time of screening:
- ① Patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average office sitting blood pressure (average of 3 measurements) of 150 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
- ② Patients who have been using a stable dose of one or two component of antihypertensive medications (including single agents, two-drug combination or two-component combinations) for at least 4 weeks prior to screening, and who, in the judgment of the clinician, can be switched to levlevamlodipine maleate tablets (2.5 mg/day) or valacyclovir capsules (80 mg/day), and whose mean office sitting blood pressure meets 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
- Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
- Medication adherence between 80% and 120% (including borderline values) during the introductory period.
Who cannot join
- Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;
- Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);
- History of malignancy within the last 5 years (with the exception of cured basal cell carcinoma of the skin, limited squamous cell carcinoma of the skin, or cervical cancer in situ), or an underlying malignancy currently under evaluation;
- Known or suspected symptomatic upright/postural hypotension ;
- Uncontrolled diabetes mellitus;
- Abnormal thyroid function;
- Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets in Patients With Mild to Moderate Essential Hypertension Not Controlled After 4 Weeks of Monotherapy With Amlodipine Or Levamlodipine Alone
SYH9056 tablets are a combination of valsartan and levamlodipine maleate. This is a multicenter, randomized, double-blind, parallel-controlled phase III study, designed to validate the efficacy and safety of SYH9056 tablets in patients with mild-to-moderate essential hypertension not controlled after 4 weeks of treatment with either levamlodipine maleate tablets or valsartan capsules, using either levamlodipine maleate tablets or valsartan capsules as a control. The study consisted of 4 phases: a screening period (2 weeks), an introduction period (4 weeks), a core treatment period (12 weeks), an extended treatment period (12 weeks), and a safety follow-up period (1 week), totaling approximately 31 weeks.
- Conditions
- Mild-to-moderate Essential Hypertension
- Being tested
- SYH9056, Levamlodipine, Valsartan, SYH9056 placebo, Levamlodipine placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH9056Drug
PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan
LevamlodipineDrug
2.5mg PO once daily
ValsartanDrug
80mg PO once daily
SYH9056 placeboDrug
PO once daily
Levamlodipine placeboDrug
PO once daily
valsartan placeboDrug
PO once daily
| Study group | Role | What they receive |
|---|---|---|
| SYH9056（levamlodipine cohort） | Experimental | Subjects will receive SYH9056 plus levamlodipine placebo for 12 weeks following a 4-weeks run-in period of levamlodipine treatment, then switch to SYH9056 treatment for 12 weeks Receives: Drug: SYH9056; Drug: Levamlodipine; Drug: Levamlodipine placebo |
| Levamlodipine（levamlodipine cohort） | Active comparator | Subjects will receive levamlodipine plus SYH9056 placebo for 12weeks following a 4-weeks run-in period of levamlodipine treatment, then switch to SYH9056 treatment for 12 weeks Receives: Drug: SYH9056; Drug: Levamlodipine; Drug: SYH9056 placebo |
| SYH9056（valsartan cohort） | Active comparator | Subjects will receive SYH9056 plus valsartan placebo for 12 weeks following a 4-weeks run-in period of valsartan treatment, then switch to SYH9056 treatment for 12 weeks Receives: Drug: SYH9056; Drug: Valsartan; Drug: valsartan placebo |
| Valsartan（valsartan cohort） | Active comparator | Subjects will receive valsartan plus SYH9056 placebo for 12weeks following a 4-weeks run-in period of valsartan treatment, then switch to SYH9056 treatment for 12 weeks Receives: Drug: SYH9056; Drug: Valsartan; Drug: SYH9056 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in mean sitting systolic blood pressure at Week 12
systolic blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start24 Jan 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-to-moderate Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, randomized, double-blind, parallel-controlled phase III study. Approximately 606 participants will be enrolled, including approximately 410 in the levamlodipine maleate cohort and 196 in the valsartan cohort, each of which was randomized in a 1:1 ratio to receive SYH9056 tablets or levamlodipine maleate tablets or valsartan capsules as monotherapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771245
- Sponsor's protocol ID
- SYH9056-002
- Status last verified
- Dec 2024
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No