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

LG Life Sciences

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Placebo; Drug: Lercanidipine + Valsartan; Drug: Lercanidipine or Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122251

LG-ZVCL001

Details and patient eligibility

About

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.

Enrollment: 441 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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441 participants in 3 patient groups, including a placebo group

Lercanidpine + Valsartan

Experimental group

Description:

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

Treatment:

Drug: Lercanidipine + Valsartan

Lercanidipine or Valsartan

Active Comparator group

Description:

L10, L20, V80, V160

Treatment:

Drug: Lercanidipine or Valsartan

Placebo

Placebo Comparator group

Description:

Placebo comparators of Lercanidipine and Valsartan

Treatment:

Drug: Placebo