Effect of CaldineĀ® on Renal Function in Balanced Hypertension

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT02240641
Collaborator
(none)
5,417

Study Details

Study Description

Brief Summary

The study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies.

Due to the contract research organisation (CRO) decision in September 2000, the database was locked and not accessible for Boehringer Ingelheim France. Consequently it was decided to stop the study and not proceed to the analysis. Thus, only safety data were processed in the safety database.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
5417 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on Protective Effect of CaldineĀ® on Renal Function in Patients With a Balanced Hypertension
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
Sep 1, 2000

Arms and Interventions

Arm Intervention/Treatment
hypertension treatment strategies

Drug: Lacidipine
Other Names:
  • Caldine
  • Drug: Diuretics

    Drug: antihypertensive drugs

    Drug: alpha blockers

    Drug: Angiotensin-Converting Enzyme Inhibitors

    Drug: beta blockers

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with adverse events [up to two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with hypertension requiring treatment
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT02240641
    Other Study ID Numbers:
    • 231.334
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Sep 16, 2014
    Last Verified:
    Sep 1, 2014

    Study Results

    No Results Posted as of Sep 16, 2014