Status:
COMPLETED
Efficacy and Safety of Lacidipine in Chronic Stable Angina
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Angina Pectoris
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT02232607
Start Date
April 1 1998
Last Update
September 5 2014
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