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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Lacidipine

• Registration Number: NCT02177331
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-06
• Primary Completion: 1998-01
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacidipine	Lacidipine	-

Primary Outcome Measures

Name	Time	Method
Number of patients with rare adverse drug reactions	up to 24 months
Change in alkaline phosphatase (AP)	up to 24 months
Change in serum glutamic - pyruvic transaminase (SGPT)	up to 24 months

Secondary Outcome Measures

Name	Time	Method
Changes in systolic and diastolic blood pressure	up to 24 months
Change in serum glutamic - oxaloacetic transaminase (SGOT)	up to 24 months
Number of patients with abnormal changes in laboratory parameters	up to 24 months
Changes in gamma glutamyl transferase (gamma-GT)	up to 24 month