Essential HypertensionPhase 2NCT01122251
Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
A Phase 2 study testing Lercanidipine + Valsartan and Lercanidipine or Valsartan in people with Essential Hypertension, run by LG Life Sciences at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Lercanidipine + Valsartan and Lercanidipine or Valsartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 441 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2009to Jul 2010
- Phase
- Phase 2
- 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 between 20 and 75
- Essential hypertension at screening (-3 week)
- Randomization Criteria:
- Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)
Who cannot join
- Mean sitDBP≥110mmHg or sitSBP≥180
- Secondary hypertension or suspected secondary hypertension
- Uncontrolled diabetes
- Severe heart disease or severe cerebrovascular disease
- clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
- History of malignant disease
- Autoimmune disease
- Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul
23 sites in Korea
Seoul, Busan Etc.
About this study
Official title: A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension
The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.
- Conditions
- Essential Hypertension
- Being tested
- Lercanidipine + Valsartan, Lercanidipine or Valsartan, Placebo
- Keywords
- hypertension, lercanidipine, valsartan
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lercanidipine + ValsartanDrug
L10/V80, L20/V80, L10/V160, L20/V160
Lercanidipine or ValsartanDrug
L10, L20, V80, V160
PlaceboDrug
Placebo of Lercanidipine and Valsartan
| Study group | Role | What they receive |
|---|---|---|
| Lercanidpine + Valsartan | Experimental | L10/V80, L20/V80, L10/V160, L20/V160 Receives: Drug: Lercanidipine + Valsartan |
| Lercanidipine or Valsartan | Active comparator | L10, L20, V80, V160 Receives: Drug: Lercanidipine or Valsartan |
| Placebo | Placebo comparator | Placebo comparators of Lercanidipine and Valsartan Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sitDBP
Average changes from baseline in sitDBP
Measured: Baseline, Week 8
Secondary outcomes (3)
sitDBP
Response rates (proportion of patients sitDBP<90mmHg or ≥10-mmHg reduction from baseline)
Measured: Week 4, 8
sitDBP
Average changes from baselin in sitDBP
Measured: Week 4
sitSBP
Average changes from baselini in sitSBP
Measured: Week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 441 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122251
- Sponsor's protocol ID
- LG-ZVCL001
- Status last verified
- Feb 2011
- First submitted
- 11 May 2010
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01122251
- Acronym / sponsor ID
- LG-ZVCL001
- Conditions
- Essential Hypertension
- Keywords
- hypertension, lercanidipine, valsartan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 May 2010 (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.
The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lercanidpine + Valsartan | Experimental | Drug: Lercanidipine + ValsartanL10/V80, L20/V80, L10/V160, L20/V160 |
| Lercanidipine or Valsartan | Active comparator | Drug: Lercanidipine or ValsartanL10, L20, V80, V160 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparators of Lercanidipine and Valsartan |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 20 and 75
- Essential hypertension at screening (-3 week)
- Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)
Key exclusion criteria (8 listed)
- Mean sitDBP≥110mmHg or sitSBP≥180
- Secondary hypertension or suspected secondary hypertension
- Uncontrolled diabetes
- Severe heart disease or severe cerebrovascular disease
- clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
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 + ValsartanL10/V80, L20/V80, L10/V160, L20/V160 | Drug | Lercanidpine + Valsartan |
| Lercanidipine or ValsartanL10, L20, V80, V160 | Drug | Lercanidipine or Valsartan |
| PlaceboPlacebo of Lercanidipine and Valsartan | Drug | Placebo |
Primary outcome
sitDBP
Time frame: Baseline, Week 8
Average changes from baseline in sitDBP
3 secondary outcomes
sitDBP
Time frame: Week 4, 8
sitDBP
Time frame: Week 4
sitSBP
Time frame: Week 4, 8
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 18 Feb 2011.
- High Blood PressureLink provided by the sponsor.
- LercanidipineLink provided by the sponsor.
- ValsartanLink provided by the sponsor.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lercanidipine + Valsartan and Lercanidipine or Valsartan in people with Essential Hypertension, run by LG Life Sciences at 2 sites 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 4 inclusion and 8 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 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
sitDBP (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2011; AzTrials last refreshed its copy on 8 Nov 2026.