Angina Pectoris
Conditions
Brief summary
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
Interventions
DRUGLacidipine, low dose
DRUGLacidipine, medium dose
DRUGLacidipine, high dose
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total treadmill exercise duration | Baseline, week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Treadmill exercise time to first report of anginal pain | week 6 |
| Reason for termination of treadmill exercise test | up to 6 weeks |
| Change in time to ST segment depression (≥ 0.1 mV) | up to 6 weeks |
| Consumption of short-acting nitrates | up to 6 weeks |
| Number of patients with adverse events | up to 6 weeks |
| Frequency/severity of anginal attacks | up to 6 weeks |
Outcome results
None listed