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

Completed

• Conditions: Hypertension
• Interventions: Drug: Motens® (lacidipine)

• Registration Number: NCT02235415
• Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 1999-09
• Status Verified: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24526

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Motens	Motens® (lacidipine)	-

Primary Outcome Measures

Name	Time	Method
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
Number of patients with adverse events	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