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Not yet recruitingNCT06771245Updated Jan 13, 2025

A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients

A Phase 3 interventional study of SYH9056 and Levamlodipine in Mild-to-moderate Essential Hypertension, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
606
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mild-to-moderate Essential Hypertension
03

In context

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 166 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18-75 (inclusive) years old;
  2. 18.0 kg/m\^2 ≤ BMI ≤ 35.0 kg/m\^2 and ≥ 50 kg for men and ≥ 45 kg for women at screening;
  3. Diagnosis of mild or moderate essential hypertension;
  4. 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;

  5. Prior to randomization, mean office sitting blood pressure meets 140 mmHg ≤ SBP \< 180 mmHg and DBP \< 110 mmHg;
  6. Medication adherence between 80% and 120% (including borderline values) during the introductory period.

Exclusion criteria

Exclusion Criteria:

  1. Rrefractory hypertension, hypertensive emergencies, hypertensive sub-emergencies and secondary hypertension;
  2. Allergy (≥ 3 drug or food allergies) or known hypersensitivity to levamlodipine, levlevamlodipine, valsartan and related drugs (dihydropyridine calcium channel blockers, angiotensin II receptor blockers);
  3. 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;
  4. Known or suspected symptomatic upright/postural hypotension ;
  5. Uncontrolled diabetes mellitus;
  6. Abnormal thyroid function;
  7. Severe cardiovascular or cerebrovascular disease within 6 months prior to screening or randomization.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
606 participants (estimated)

Study arms

  • Experimental
    SYH9056(levamlodipine cohort)

    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

    Drug: SYH9056 · Drug: Levamlodipine · Drug: Levamlodipine placebo

  • Active comparator
    Levamlodipine(levamlodipine cohort)

    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

    Drug: SYH9056 · Drug: Levamlodipine · Drug: SYH9056 placebo

  • Active comparator
    SYH9056(valsartan cohort)

    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

    Drug: SYH9056 · Drug: Valsartan · Drug: valsartan placebo

  • Active comparator
    Valsartan(valsartan cohort)

    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

    Drug: SYH9056 · Drug: Valsartan · Drug: SYH9056 placebo

Interventions

  • DrugSYH9056

    PO once daily, 1 tablet each time, each tablet contains 2.5mg levamlodipine and 80mg valsartan

  • 2.5mg PO once daily

  • 80mg PO once daily

  • DrugSYH9056 placebo

    PO once daily

  • DrugLevamlodipine placebo

    PO once daily

  • Drugvalsartan placebo

    PO once daily

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At Week 12

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Mar 2026, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2025
First posted
Jan 13, 2025
StartEst.
Jan 24, 2025
Primary completionEst.
Mar 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Jan 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06771245
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Jan 24, 2025 (estimated)
Primary completion
Mar 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Jan 13, 2025

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
86-0311-69085587

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Levamlodipine

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