Last reviewed · How we verify
NCT01819441: APPROVE
Azelnidipine vs Perindopril and Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients (APPROVE):Multi-center Randomized Controlled Clinical Trial
Phase 4 trial testing Azelnidipine in Cerebral Small Vessel Diseases in 1,200 participants. Status unknown.
1 December 2016
Quick facts
| Lead sponsor | Yining Huang |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,200 |
| Start date | 1 May 2012 |
| Primary completion | 1 December 2016 |
| Estimated completion | 1 December 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Azelnidipine (AZELNIDIPINE) — full drug profile →
- Perindopril — full drug profile →
- hydrochlorothiazide (hydrochlorothiazide) — full drug profile →
Conditions studied
- Cerebral Small Vessel Diseases — all drugs for Cerebral Small Vessel Diseases →
Sponsor
Yining Huang
Who can join
Adults 40 to 85, any sex, with Cerebral Small Vessel Diseases. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cerebral Small Vessel Disease progressing
Time frame: two years
Area of WML increase more than 4% or Number of CMBs increase more than 2
Sponsor's own description
A. the controlling of the blood pressure, especially the variation of blood pressure, can slow down the development of the small vessel disease. B intensive BP control is more effective than normal control of blood pressure in slowing down the small vessel disease. C drugs of Calcium Channel Blocker(CCB) and Angiotensin-Converting Enzyme Inhibitor(ACEI) have no significant difference in lowing the blood pressure and variability of blood pressure
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01819441
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cerebral Small Vessel Diseases
Currently open trials in the same condition.
- NCT07342075 — Registry Study of Cerebral Small Vessel Disease · recruiting
- NCT06579664 — Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease · NA · recruiting
- NCT06416371 — Retinal Vessel Leakage in Cerebral Small Vessel Disease · recruiting
- NCT06431711 — Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease · recruiting
- NCT06164262 — Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years · 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 NCT01819441 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yining Huang
- Last refreshed: 22 October 2015
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/NCT01819441.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing