Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients

NCT01928628

Hypertension

COMPLETED PHASE3

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

NCT00280540

Hypertension

COMPLETED PHASE4

Observational Study to Evaluate the Safety and Efficacy for Levacalm Tab. Versus Valsartan/Amlodipine Combination Therapy in Essential Hypertension Patients

NCT02415192

Lower Leg Edema Orthostatic Hypertension

UNKNOWN

Valsartan Intensified Primary Care Reduction of Blood Pressure Study

NCT00902304

Hypertension

COMPLETED PHASE4

Antihypertensive Efficacy of Fixed Combination Drug

NCT01211314

Hypertension

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lercanidpine + Valsartan

L10/V80, L20/V80, L10/V160, L20/V160

Group Type EXPERIMENTAL

Lercanidipine + Valsartan

Intervention Type DRUG

L10/V80, L20/V80, L10/V160, L20/V160

Lercanidipine or Valsartan

L10, L20, V80, V160

Group Type ACTIVE_COMPARATOR

Lercanidipine or Valsartan

Intervention Type DRUG

L10, L20, V80, V160

Placebo

Placebo comparators of Lercanidipine and Valsartan

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of Lercanidipine and Valsartan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lercanidipine + Valsartan

L10/V80, L20/V80, L10/V160, L20/V160

Intervention Type DRUG

Lercanidipine or Valsartan

L10, L20, V80, V160

Intervention Type DRUG

Placebo

Placebo of Lercanidipine and Valsartan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged between 20 and 75
* Essential hypertension at screening (-3 week)

Randomization Criteria:

* Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No