HypertensionPhase 3NCT01928628
Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients
A Phase 3 study testing Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg and Lercanidipine 10mg /Valsartan 160mg in people with Hypertension, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg and Lercanidipine 10mg /Valsartan 160mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 20 to ≤75 years old
- Patient with essential hypertension
Who cannot join
- When the BP level measured at screening was sitDBP>120 mmHg or sitSBP >180 mmHg
- Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.
This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension
- Conditions
- Hypertension
- Being tested
- Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg, Lercanidipine 10mg /Valsartan 160mg, Lercanidipin 10mg Placebo, Lercanidipine10mg /Valsartan 80mg Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lercanidipine 10mgDrug
Lercanidipine10mg /Valsartan 80mgDrug
Lercanidipine 10mg /Valsartan 160mgDrug
Lercanidipin 10mg PlaceboDrug
Lercanidipine10mg /Valsartan 80mg PlaceboDrug
Lercanidipine 10mg /Valsartan 160mg PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lercanidipine 10mg | Active comparator | 1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks) Receives: Drug: Lercanidipine 10mg; Drug: Lercanidipine10mg /Valsartan 80mg Placebo; Drug: Lercanidipine 10mg /Valsartan 160mg Placebo |
| Lercanidipine10mg /Valsartan 80mg | Experimental | 1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks) Receives: Drug: Lercanidipine10mg /Valsartan 80mg; Drug: Lercanidipin 10mg Placebo; Drug: Lercanidipine 10mg /Valsartan 160mg Placebo |
| Lercanidipine 10mg /Valsartan 160mg | Experimental | 1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks) Receives: Drug: Lercanidipine 10mg /Valsartan 160mg; Drug: Lercanidipin 10mg Placebo; Drug: Lercanidipine10mg /Valsartan 80mg Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean sitDBP from week 0 to week 40
Measured: 40 weeks
Secondary outcomes (1)
Response rate at week 4 and 8
Proportion (%) of patients with mean sitDBP<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928628
- Sponsor's protocol ID
- LG-ZVCL005
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Na SH, Lee HY, Hong Baek S, Jeon HK, Kang JH, Kim YN, Park CG, Ryu JK, Rhee MY, Kim MH, Hong TJ, Choi DJ, Cho SW, Cha DH, Jeon ES, Kim JJ, Shin JH, Park SH, Lee SH, John SH, Shin ES, Kim NH, Lee SY, Kwan J, Jeong MH, Kim SW, Jeong JO, Kim DW, Lee NH, Park WJ, Ahn JC, Won KH, Uk Lee S, Cho JH, Kim SK, Ahn T, Hong S, Yoo SY, Kim SY, Kim BS, Juhn JH, Kim SY, Lee YJ, Oh BH. Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clin Ther. 2015 Aug;37(8):1726-39. doi: 10.1016/j.clinthera.2015.05.512. Epub 2015 Jul 8.
PubMed 26164786
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.
- ClinicalTrials.gov ID
- NCT01928628
- Acronym / sponsor ID
- LG-ZVCL005
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lercanidipine 10mg | Active comparator | Drug: Lercanidipine 10mg, Drug: Lercanidipine10mg /Valsartan 80mg Placebo, Drug: Lercanidipine 10mg /Valsartan 160mg Placebo1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks) |
| Lercanidipine10mg /Valsartan 80mg | Experimental | Drug: Lercanidipine10mg /Valsartan 80mg, Drug: Lercanidipin 10mg Placebo, Drug: Lercanidipine 10mg /Valsartan 160mg Placebo1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks) |
| Lercanidipine 10mg /Valsartan 160mg | Experimental | Drug: Lercanidipine 10mg /Valsartan 160mg, Drug: Lercanidipin 10mg Placebo, Drug: Lercanidipine10mg /Valsartan 80mg Placebo1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 20 to ≤75 years old
- Patient with essential hypertension
Key exclusion criteria (2 listed)
- When the BP level measured at screening was sitDBP>120 mmHg or sitSBP >180 mmHg
- Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lercanidipine 10mg | Drug | Lercanidipine 10mg |
| Lercanidipine10mg /Valsartan 80mg | Drug | Lercanidipine10mg /Valsartan 80mg |
| Lercanidipine 10mg /Valsartan 160mg | Drug | Lercanidipine 10mg /Valsartan 160mg |
| Lercanidipin 10mg Placebo | Drug | Lercanidipine 10mg /Valsartan 160mg, Lercanidipine10mg /Valsartan 80mg |
| Lercanidipine10mg /Valsartan 80mg Placebo | Drug | Lercanidipine 10mg, Lercanidipine 10mg /Valsartan 160mg |
| Lercanidipine 10mg /Valsartan 160mg Placebo | Drug | Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg |
Primary outcome
Change in mean sitDBP from week 0 to week 40
Time frame: 40 weeks
1 secondary outcome
Response rate at week 4 and 8
Time frame: 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Derived from this study: PubMed 26164786Na SH, Lee HY, Hong Baek S, Jeon HK, Kang JH, Kim YN, Park CG, Ryu JK, Rhee MY, Kim MH, Hong TJ, Choi DJ, Cho SW, Cha DH, Jeon ES, Kim JJ, Shin JH, Park SH, Lee SH, John SH, Shin ES, Kim NH, Lee SY, Kwan J, Jeong MH, Kim SW, Jeong JO, Kim DW, Lee NH, Park WJ, Ahn JC, Won KH, Uk Lee S, Cho JH, Kim SK, Ahn T, Hong S, Yoo SY, Kim SY, Kim BS, Juhn JH, Kim SY, Lee YJ, Oh BH. Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clin Ther. 2015 Aug;37(8):1726-39. doi: 10.1016/j.clinthera.2015.05.512. Epub 2015 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lercanidipine 10mg, Lercanidipine10mg /Valsartan 80mg and Lercanidipine 10mg /Valsartan 160mg in people with Hypertension, run by LG Life Sciences at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean sitDBP from week 0 to week 40 (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013; AzTrials last refreshed its copy on 1 Nov 2026.