Trials / Recruiting
RecruitingNCT07367724
Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ademetionine 1,4-Butanedisulfonate | Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China. |
| DRUG | Placebo | The placebo is a starch tablet identical in appearance, odor, and other physical properties. |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2026-01-26
- Last updated
- 2026-03-20
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07367724. Inclusion in this directory is not an endorsement.