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NCT05169021: FAITH
Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD
Phase 4 trial testing Amlodipine folic acid 5.8mg+intensive antihypertensive therapy in Cerebral Small Vessel Diseases in 15,000 participants. Not yet recruiting.
31 December 2024
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 15,000 |
| Start date | 31 December 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Amlodipine folic acid 5.8mg+intensive antihypertensive therapy — full drug profile →
- Amlodipine folic acid 5.8mg+standard antihypertensive therapy — full drug profile →
- Amlodipine+intensive antihypertensive therapy — full drug profile →
- Amlodipine+standard antihypertensive therapy — full drug profile →
Conditions studied
- Cerebral Small Vessel Diseases — all drugs for Cerebral Small Vessel Diseases →
- Stroke — all drugs for Stroke →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 35 to 75, any sex, with Cerebral Small Vessel Diseases or Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objectives of this trial are: 1. Efficacy evaluation of amlodipine folic acid tablets: To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level. 2. Intensive Antihypertensive Therapy: To assess the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cerebral Small Vessel Disease: Therapeutic Approaches Targeting Neuroinflammation, Oxidative Stress, and Endothelial Dysfunction.
Yılmaz H, Bayraktutan U. · · 2025 · cited 3× · PMID 40699631 · DOI 10.3390/cimb47040232
Verify or expand the search:
- PubMed search for NCT05169021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
- NCT07341854 — Dexamethasone Palmitate for Postoperative Pain · NA · not yet recruiting
- NCT07527013 — Stratified Blood Pressure Management Strategy After Endovascular Treatment for Acute Ischemic Stroke · Phase 3 · not yet recruiting
- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05169021 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 23 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05169021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing