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

NCT ID: NCT02177331

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-06-30

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lacidipine

Group Type: EXPERIMENTAL

Lacidipine

Intervention Type: DRUG

Interventions

Lacidipine

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

231.215

Identifier Type: -

Identifier Source: org_study_id