Angina PectorisPhase 2NCT02232607
Efficacy and Safety of Lacidipine in Chronic Stable Angina
A Phase 2 study testing Lacidipine, low dose, Lacidipine, medium dose and Lacidipine, high dose in people with Angina Pectoris, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Lacidipine, low dose, Lacidipine, medium dose and Lacidipine, high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Jun 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
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.
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
- Conditions
- Angina Pectoris
- Being tested
- Lacidipine, low dose, Lacidipine, medium dose, Lacidipine, high dose, Placebo
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidipine, low doseDrug
Lacidipine, medium doseDrug
Lacidipine, high doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lacidipine, low dose | Experimental | Not described Receives: Drug: Lacidipine, low dose; Drug: Placebo |
| Lacidipine, medium dose | Experimental | Not described Receives: Drug: Lacidipine, medium dose; Drug: Placebo |
| Lacidipine, high dose | Experimental | Not described Receives: Drug: Lacidipine, high dose |
| Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total treadmill exercise duration
Measured: Baseline, week 6
Secondary outcomes (6)
Change in time to ST segment depression (≥ 0.1 mV)
Measured: up to 6 weeks
Treadmill exercise time to first report of anginal pain
Measured: week 6
Reason for termination of treadmill exercise test
Measured: up to 6 weeks
Frequency/severity of anginal attacks
Measured: up to 6 weeks
Consumption of short-acting nitrates
Measured: up to 6 weeks
Number of patients with adverse events
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startApr 1998
- Primary completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232607
- Sponsor's protocol ID
- 231.339
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02232607
- Acronym / sponsor ID
- 231.339
- Conditions
- Angina Pectoris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Jun 1999 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lacidipine, low dose | Experimental | Drug: Lacidipine, low dose, Drug: Placebo |
| Lacidipine, medium dose | Experimental | Drug: Lacidipine, medium dose, Drug: Placebo |
| Lacidipine, high dose | Experimental | Drug: Lacidipine, high dose |
| Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacidipine, low dose | Drug | Lacidipine, low dose |
| Lacidipine, medium dose | Drug | Lacidipine, medium dose |
| Lacidipine, high dose | Drug | Lacidipine, high dose |
| Placebo | Drug | Lacidipine, low dose, Lacidipine, medium dose, Placebo |
Primary outcome
Change in total treadmill exercise duration
Time frame: Baseline, week 6
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacidipine, low dose, Lacidipine, medium dose and Lacidipine, high dose in people with Angina Pectoris, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total treadmill exercise duration (time frame: Baseline, week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.