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OpenTrials
Completed

NCT Number: NCT02177331

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacidipine

Drug

Primary outcomes

  1. Number of patients with rare adverse drug reactions

    Time frame: up to 24 months

  2. Change in alkaline phosphatase (AP)

    Time frame: up to 24 months

  3. Change in serum glutamic - pyruvic transaminase (SGPT)

    Time frame: up to 24 months

Secondary outcomes

  1. Change in serum glutamic - oxaloacetic transaminase (SGOT)

    Time frame: up to 24 months

  2. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 24 months

  3. Changes in systolic and diastolic blood pressure

    Time frame: up to 24 months

  4. Changes in gamma glutamyl transferase (gamma-GT)

    Time frame: up to 24 month

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Lacidipine in Medical Practice: Incidence of Rare Adverse Drug Reactions During Long-term Treatment. 3rd Follow-up Study - Long-term Use in the 4th and 5th Year Treatment Years

Important dates

Study start
1995
Primary completion
1998
First posted
Jun 27, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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