Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension

Lead Sponsor:

Novartis

Collaborating Sponsors:

Great Lakes Drug Development, Inc.

Integrium

Conditions:

Hypertension

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and \<180 mmHg
  • Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
  • Male and female participants 18 to 75 years of age
  • Exclusion criteria:
  • Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
  • Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
  • Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c \[HbA1c\] \>9%)
  • Malignancies within the last 5 years (excluding basal cell skin cancer)
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion

    Key Trial Info

    Start Date :

    December 22 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 13 2009

    Estimated Enrollment :

    155 Patients enrolled

    Trial Details

    Trial ID

    NCT00817635

    Start Date

    December 22 2008

    End Date

    October 13 2009

    Last Update

    June 2 2021

    Active Locations (38)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (38 locations)

    1

    Horizon Research Group, Inc

    Mobile, Alabama, United States, 36608

    2

    Cochise Clinical Research

    Sierra Vista, Arizona, United States, 85635

    3

    Clinical Solutions Advantage

    Buena Park, California, United States, 90620

    4

    Michael Waldman, MD

    Irvine, California, United States, 92618