Clinical trial NCT02232607: Efficacy and Safety of Lacidipine in Chronic Stable Angina
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Angina Pectoris
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-05
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in total treadmill exercise duration
timeFrame: Baseline, week 6
Secondary outcomes:
measure: Change in time to ST segment depression (≥ 0.1 mV)
timeFrame: up to 6 weeks
measure: Treadmill exercise time to first report of anginal pain
timeFrame: week 6
measure: Reason for termination of treadmill exercise test
timeFrame: up to 6 weeks
measure: Frequency/severity of anginal attacks
timeFrame: up to 6 weeks
measure: Consumption of short-acting nitrates
timeFrame: up to 6 weeks
measure: Number of patients with adverse events
timeFrame: up to 6 weeks
Other outcomes:
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