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NCT00627952
Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
Phase 3 trial testing amlodipine 10 mg in Hypertension in 100 participants. Completed in 1 December 2008.
1 December 2008
Quick facts
| Lead sponsor | University of Erlangen-Nürnberg Medical School |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 November 2007 |
| Primary completion | 1 December 2008 |
| Estimated completion | 1 December 2008 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- amlodipine 10 mg
- manidipine 20 mg — full drug profile →
- amlodipine 5 mg + delapril 30 mg — full drug profile →
- manidipine 10 mg + delapril 30 mg — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
University of Erlangen-Nürnberg Medical School
Who can join
Adults 18 to 65, any sex, with Hypertension. 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.
-
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
Time frame: 4 weeks
Sponsor's own description
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Retinal capillary rarefaction in patients with untreated mild-moderate hypertension.
Bosch AJ, Harazny JM, Kistner I, Friedrich S, et al · · 2017 · cited 41× · PMID 29268712 · DOI 10.1186/s12872-017-0732-x -
Effects of manidipine vs. amlodipine on intrarenal haemodynamics in patients with arterial hypertension.
Ott C, Schneider MP, Raff U, Ritt M, et al · · 2013 · cited 23× · PMID 23240643 · DOI 10.1111/j.1365-2125.2012.04336.x -
Retinal Capillary Rarefaction in Patients with Type 2 Diabetes Mellitus.
Jumar A, Harazny JM, Ott C, Friedrich S, et al · · 2016 · cited 19× · PMID 27935938 · DOI 10.1371/journal.pone.0162608
Verify or expand the search:
- PubMed search for NCT00627952
- 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 University of Erlangen-Nürnberg Medical School trials
Trials by the same sponsor.
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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 NCT00627952 (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 University of Erlangen-Nürnberg Medical School
- Last refreshed: 18 January 2013
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/NCT00627952.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing