Efficacy and Safety of Lacidipine in Chronic Stable Angina

Overview

The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina

Full Title of Study: “A Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Lacidipine in Chronic Stable Angina.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: June 1999

Interventions

  • Drug: Lacidipine, low dose
  • Drug: Lacidipine, medium dose
  • Drug: Lacidipine, high dose
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Lacidipine, low dose
  • Experimental: Lacidipine, medium dose
  • Experimental: Lacidipine, high dose
  • Active Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in total treadmill exercise duration
    • Time Frame: Baseline, week 6

Secondary Measures

  • Change in time to ST segment depression (≥ 0.1 mV)
    • Time Frame: up to 6 weeks
  • Treadmill exercise time to first report of anginal pain
    • Time Frame: week 6
  • Reason for termination of treadmill exercise test
    • Time Frame: up to 6 weeks
  • Frequency/severity of anginal attacks
    • Time Frame: up to 6 weeks
  • Consumption of short-acting nitrates
    • Time Frame: up to 6 weeks
  • Number of patients with adverse events
    • Time Frame: up to 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 to 80 years
  • History of stable, exertional angina pectoris (Canadian Cardiovascular Society functional class II to III) for at least 3 months duration prior to enrolment in the study
  • Patients not currently receiving treatment with antianginal medication (other than short-acting nitrates)
  • Between visits 2 and 3 two treadmill exercise tests, demonstrating ≥ 0.1 mV of horizontal or down sloping ST-segment depression, must be carried out. The difference in symptom-limited exercise duration between these two tests must not exceed 20%
  • Total treadmill exercise duration > 3 minutes (i.e. stage 2 or above on a standard Bruce protocol)
  • Coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating ≥ 50% reduction in luminal diameter of one or more coronary arteries or their primary branches

Exclusion Criteria

  • Myocardial infarction within 3 months prior to enrolment in the study
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within 6 months
  • Other types of angina (variant, unstable)
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
  • Resting heart rate < 50 bpm or > 100 bpm
  • Significant valvular heart disease
  • Heart failure New York Heart Association Class III or IV
  • Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication
  • Significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block, intraventricular conduction defect (QRS > 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium < 3.5 mmol/litre)
  • Insulin dependent diabetes mellitus
  • Significant liver disease (Aspartate Aminotransferase or Alanine Aminotransferase > twice the upper limit of reference range)
  • Significant renal disease (creatinine > 1.5 x upper limit of reference range)
  • Any clinical condition which in the opinion of the investigator, would preclude the safe fulfilment of the protocol and the safe administration of trial medication
  • Inability to perform repeated exercise testing due to extra-cardiac reasons
  • Concomitant treatment with any other anti-anginal medication, whether or not prescribed for this indication (e.g. calcium channel blockers, β-blockers or long-acting nitrates)
  • Concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic anti-depressants or other agents known to affect ST-segment morphology
  • Known hypersensitivity to any of the components of the investigational drug
  • Pregnant or nursing women or women of child bearing potential
  • Participation in any other clinical trial within 2 months of enrolment
  • History of drug or alcohol abuse

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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