Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension

September 9, 2014 updated by: Boehringer Ingelheim

Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension, Under Normal Conditions Compared With an Open Clinical Trial

Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24526

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with essential Hypertension recruited by General practicioners, cardiologists and specialists in internal medicine in non-Hospital practice

Description

Inclusion Criteria:

Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension

Exclusion Criteria:

Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Motens
Drug: Motens® (lacidipine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure
Time Frame: Up to 12 weeks after start of drug administration
Up to 12 weeks after start of drug administration
Assessment of tolerability by investigator on a 4-point verbal rating scale
Time Frame: Up to 12 weeks after start of drug administration
Up to 12 weeks after start of drug administration
Number of patients with adverse events
Time Frame: Up to 12 weeks after start of drug administration
Up to 12 weeks after start of drug administration

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, 1998

Primary Completion (Actual)

September 1, 1999

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231.340

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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