NCT02235415

Brief Summary

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24,526

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1999

Completed
15 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
Last Updated

September 10, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

September 9, 2014

Last Update Submit

September 9, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure

    Up to 12 weeks after start of drug administration

  • Assessment of tolerability by investigator on a 4-point verbal rating scale

    Up to 12 weeks after start of drug administration

  • Number of patients with adverse events

    Up to 12 weeks after start of drug administration

Study Arms (1)

Motens

Drug: Motens® (lacidipine)

Interventions

Motens® (lacidipine)DRUG
Motens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

lacidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 10, 2014

Study Start

June 1, 1998

Primary Completion

September 1, 1999

Last Updated

September 10, 2014

Record last verified: 2014-09