Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension

July 11, 2014 updated by: Boehringer Ingelheim

Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years

In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fulfillment of entry criteria for the preceding yearly study
  • Male or female patients aged between 20 and 85 years
  • Known history of mild to moderate essential hypertension requiring drug treatment, WHO grade I to II
  • Controlled blood pressure (RR diastolic ≤ 90 mm Hg or 91 - 95 mm Hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day
  • Final visit of the previous yearly study (Visit 4) completed as scheduled
  • Informed consent to participate in the follow-up study

Exclusion Criteria:

  • Violation of entry/exclusion criteria on enrolment in the preceding yearly study

  • Occurrence of the following exclusion criteria in the intervening period:

    • Pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception
    • Secondary form of hypertension
    • Consumptive illness
    • Clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (NYHA Class III or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia
    • Myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study
    • Hypersensitivity to dihydropyridines
    • Concomitant long-term treatment (> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants
    • Suspected alcohol, narcotic or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lacidipine
Drug: Lacidipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with rare adverse drug reactions
Time Frame: up to 24 months
up to 24 months
Change in alkaline phosphatase (AP)
Time Frame: up to 24 months
up to 24 months
Change in serum glutamic - pyruvic transaminase (SGPT)
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum glutamic - oxaloacetic transaminase (SGOT)
Time Frame: up to 24 months
up to 24 months
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 24 months
up to 24 months
Changes in systolic and diastolic blood pressure
Time Frame: up to 24 months
up to 24 months
Changes in gamma glutamyl transferase (gamma-GT)
Time Frame: up to 24 month
up to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1995

Primary Completion (Actual)

January 1, 1998

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231.215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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