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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Lacidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177331

231.215

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Lacidipine

Experimental group

Treatment:

Drug: Lacidipine