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NCT00940667
A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy
Phase 3 trial testing Amlodipine plus Losartan in Hypertension in 185 participants. Completed in 1 December 2008.
1 December 2008
Quick facts
| Lead sponsor | Hanmi Pharmaceutical Company Limited |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 185 |
| Start date | 1 May 2008 |
| Primary completion | 1 December 2008 |
| Estimated completion | 1 December 2008 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Amlodipine plus Losartan — full drug profile →
- Amlodipine (amlodipine) — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Hanmi Pharmaceutical Company Limited — full company profile →
Who can join
18 and older, 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.
-
Change from baseline in mean sitting diastolic blood pressure
Time frame: Week 8
Sponsor's own description
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority
Kang SM, Youn JC, Chae SC, Park CG, et al · · 2011 · cited 14× · PMID 22136978 · DOI 10.1016/j.clinthera.2011.11.007 -
Evaluation of blood pressure reduction response and responder characteristics to fixed-dose combination treatment of amlodipine and losartan: a post hoc analysis of pooled clinical trials.
Unniachan S, Wu D, Rajagopalan S, Hanson ME, et al · · 2014 · cited 5× · PMID 25098858 · DOI 10.1111/jch.12390
Verify or expand the search:
- PubMed search for NCT00940667
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amlodipine plus Losartan
Trials testing the same drug.
- NCT03912285 — The Pharmacokinetic Interaction Between Amlodipine and Losartan · Phase 1 · completed
Other recruiting trials for Hypertension
Currently open trials in the same condition.
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- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Hanmi Pharmaceutical Company Limited trials
Trials by the same sponsor.
- NCT07297693 — A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers · Phase 1 · not yet recruiting
- NCT06595004 — A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients · Phase 3 · completed
- NCT06518122 — A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers · Phase 1 · completed
- NCT06481098 — A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects. · Phase 1 · completed
- NCT06357910 — A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy V · Phase 1 · completed
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 NCT00940667 (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 Hanmi Pharmaceutical Company Limited
- Last refreshed: 10 October 2016
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/NCT00940667.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing