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NCT02415192
A Multicenter, Prospective Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Patient With Essential Hypertension
trial testing Levacalm in Lower Leg Edema in 2,001 participants. Status unknown.
1 October 2016
Quick facts
| Lead sponsor | LG Life Sciences |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 2,001 |
| Start date | 1 July 2014 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 November 2016 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Levacalm — full drug profile →
- Valsartan/amlodipine — full drug profile →
Conditions studied
- Lower Leg Edema — all drugs for Lower Leg Edema →
- Orthostatic Hypertension — all drugs for Orthostatic Hypertension →
Sponsor
LG Life Sciences — full company profile →
Who can join
19 and older, any sex, with Lower Leg Edema or Orthostatic 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.
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Safety of each group by observing the Adverse events especially detecting the incidence of lower leg edema and orthostatic hypertension by subject questionnaire.
Time frame: 6month
Sponsor's own description
Levacalm Tab. was approved in Jul 2013 by MFDS in South Korea. Levacalm Tab. is combination drug of Valsartan as an angiotensin II receptor blocker and Lercanidipine as a Calcium channel blocker. It is a new drug of combination of Valsartan and Lercanidipine. Thus, there's no enough safety data and efficacy data defined from the clinical study. Also, many combination drugs of valsartaa and amlodipine are widely used in the market. LGLS will compare the safety(adverse events especially the lower leg edema) and efficacy (blood pressure and pulse) of Levacalm and Valsartan/amlodipine combination drug from this study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Improving computational drug repositioning through multi-source disease similarity networks.
Le DH. · · 2025 · cited 1× · PMID 40841559 · DOI 10.1038/s41598-025-04772-0
Verify or expand the search:
- PubMed search for NCT02415192
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other LG Life Sciences trials
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- NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy · Phase 3 · completed
- NCT02290301 — An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin · 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 NCT02415192 (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 LG Life Sciences
- Last refreshed: 18 April 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/NCT02415192.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing