Efficacy and Safety of Lacidipine in Chronic Stable Angina
CompletedPhase 2NCT02232607
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- 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.
- Conditions
- Interventions
- Drug: Lacidipine, low dose
- Drug: Lacidipine, medium dose
- Drug: Lacidipine, high dose
- Drug: Placebo
- Sponsor
- Boehringer Ingelheim
- Start date
- 1998-04
- Primary completion
- 1999-06
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 * Concomi…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02232607