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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122251
• Other study ID #: LG-ZVCL001
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2010
• Last updated: February 17, 2011
• Start date: December 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Lercanidipine + Valsartan
L10/V80, L20/V80, L10/V160, L20/V160
• Lercanidipine or Valsartan
L10, L20, V80, V160
• Placebo
Placebo of Lercanidipine and Valsartan

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	23 sites in Korea	Seoul, Busan etc.

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sitDBP	Average changes from baseline in sitDBP	Baseline, Week 8	No
Secondary	sitDBP	Response rates (proportion of patients sitDBP<90mmHg or =10-mmHg reduction from baseline)	Week 4, 8	No
Secondary	sitDBP	Average changes from baselin in sitDBP	Week 4	No
Secondary	sitSBP	Average changes from baselini in sitSBP	Week 4, 8	No

External Links

•   High Blood Pressure
•   Lercanidipine
•   Valsartan