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Heart FailurePhase 2NCT00682565

PK and Tolerability of IV and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina

A Phase 2 study testing CK-1827452 24mg and 6 mg iv infusion, CK-1827452 12.5mg capsule and CK-1827452 48 mg and 11 mg iv infusion in people with Heart Failure and Myocardial Ischemia, run by Cytokinetics at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CK-1827452 24mg and 6 mg iv infusion, CK-1827452 12.5mg capsule and CK-1827452 48 mg and 11 mg iv infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
14 sitesin 2 countries
Study dates
Apr 2008to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has signed an Informed Consent Form/Patient Information Sheet for this study approved by the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • The patient is at least 18 years old.
  • The patient has ischemic heart disease documented by any one or more of the following:
  • A history of myocardial infarction documented by elevated CPK-MB, troponin I or T, or the presence of electrocardiographic Q waves consistent with myocardial infarction.
  • Coronary angiography demonstrating at least 1 major epicardial coronary artery (i.e., left main, left anterior descending, left circumflex, or right coronary artery) with a stenosis of at least 60% diameter or greater but excluding stenosis of the left main coronary artery unless revascularized by coronary artery bypass grafting.
  • The patient has a history of ≥ 1 episode of exercise induced angina within 2 months prior to the initial screening visit.
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  • The patient has been taking a beta blocker and an ACE inhibitor (and/or an ARB) for at least 4 weeks. If prescribed, diuretics must have been administered for at least 4 weeks prior to the initial screening visit.
  • The patient is NYHA Class II-III at the time of enrollment and has been so for ≥ 3 months prior to the initial screening visit.
  • The patient has a history of a left ventricular ejection fraction (LVEF) ≤ 35%.
  • The patient has a history of EITHER a left ventricular end-diastolic diameter ≥ 55 mm, OR a left ventricular end-diastolic diameter index ≥ 32 mm/m2.
  • The patient can be expected to complete at least 4 minutes of a Modified Naughton ETT (see Appendix B).
  • For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices.

Who cannot join

  • The patient has acute myocarditis; clinically significant restrictive, constrictive, or hypertrophic obstructive cardiomyopathy; or clinically significant congenital heart disease.
  • The patient has a SBP > 160 mmHg, documented on at least 3 separate occasions, at least 10 minutes apart.
  • The patient has a DBP > 90 mmHg, documented on at least 3 separate occasions, at least 10 minutes apart.
  • The patient has levels of troponin I or T, or CPK-MB > the upper limit of normal at any time from 6 weeks prior to the Initial Screening Visit (Visit 1) and up to randomization.
  • The patient has severe aortic or mitral stenosis.
  • The patient has had an acute coronary syndrome, transient ischemic attack, or revascularization procedure within 6 weeks of the Initial Screening Visit (Visit 1).
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  • The patient has significant co-morbid conditions (i.e., lung disease, arthritis, peripheral vascular disease) that may limit his or her treadmill exercise capacity.
  • The patient has renal impairment defined by a calculated creatinine clearance < 30 cc/min or a need for renal replacement therapy.
  • The patient has known hepatic impairment defined by a total bilirubin > 3 mg/dL, or an ALT or AST > 2 times the upper limit of normal.
  • The patient has received an investigational drug or device within 30 days or 5 half-lives, whichever is greater, of randomization.
  • The patient weighs > 120 kg.
  • The patient has a body temperature > 38 ° C, confirmed by at least 2 successive measurements, at least 10 minutes apart.
  • The patient has any laboratory abnormality which, in the opinion of the investigator, should preclude his or her participation in the study.
  • The patient has had any prior treatment with CK-1827452.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Russia8 sites

  • Altay Territory Cardiology Dispensary

    Barnaul

  • City Hospital #1

    Barnaul

  • City Clinical Hospital #59

    Moscow

  • City Clinical Hospital #64

    Moscow

  • Moscow Municipal Clinical Hospital #4

    Moscow

  • Federal Center of Heart, Blood and Endocrinology n.a. Almazov

    Saint Petersburg

  • Research Centre for Cardiology n.a. Almazov under Roszdrav

    Saint Petersburg

  • Volgograd Regional Cardiology Center

    Volgograd

Other trials in Russia

Georgia6 sites

  • Tbilisi State Medical University Clinic #1

    Tbilisi, 0102

  • Cardio-Reanimation Centre

    Tbilisi, 0141

  • Cardiology Clinic

    Tbilisi, 0144

  • National Center of Therapy

    Tbilisi, 0159

  • Multiprofile Clinical Hospital of Tbilisi #2

    Tbilisi, 0164

  • Diagnostic Services Clinic

    Tbilisi, 0179

Other trials in Georgia

About this study

Official title: Tolerability and CK-1827452 Plasma Concentrations During Intravenous and Immediate-Release Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina

This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.

Read the detailed description

The primary objective of this study is to assess the effect of intravenous (i.v.) CK-1827452 on symptom-limited exercise tolerance in patients with ischemic cardiomyopathy and angina. The secondary objectives are to assess the tolerability of CK-1827452 administered three times daily (tid) to steady state in an immediate-release (IR), blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina and to assess CK-1827452 plasma concentrations at trough and 1 hour after dosing with CK-1827452 administered tid to steady state in an IR, blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina.

Being tested
CK-1827452 24mg and 6 mg iv infusion, CK-1827452 12.5mg capsule, CK-1827452 48 mg and 11 mg iv infusion, CK-1827452 25mg capsule, Placebo iv infusion
Medical subject headings
Heart Failure, Myocardial Ischemia, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CK-1827452 24mg and 6 mg iv infusionDrug

    Also called omecamtiv mecarbil

    I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr

  • CK-1827452 12.5mg capsuleDrug

    Also called omecamtiv mecarbil

    12.5mg oral immediate release capsule

  • CK-1827452 48 mg and 11 mg iv infusionDrug

    Also called omecamtiv mecarbil

    I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr

  • CK-1827452 25mg capsuleDrug

    Also called omecamtiv mecarbil

    25mg oral immediate release capsule

  • Placebo iv infusionDrug

    Matching placebo iv infusion

  • Placebo capsuleDrug

    Matching placebo oral immediate release capsule

Study groups in NCT00682565
Study groupRoleWhat they receive
Mid Dose CK-1827452 or PlaceboExperimentalCK-1827452 I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose
Receives: Drug: CK-1827452 24mg and 6 mg iv infusion; Drug: CK-1827452 12.5mg capsule; Drug: Placebo iv infusion; Drug: Placebo capsule
High Dose CK-1827452 or PlaceboExperimentalCK-1827452 I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose
Receives: Drug: CK-1827452 48 mg and 11 mg iv infusion; Drug: CK-1827452 25mg capsule; Drug: Placebo iv infusion; Drug: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)

    The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.

    Measured: 1 day

Secondary outcomes (4)

  1. Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B

    The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.

    Measured: 1 day

  2. Increase in Exercise Duration During ETT-3 vs. ETT-B

    Measured: 1 day

  3. Participants Stopping ETT-3 for Angina at Any Stage

    This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B.

    Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina.

    Measured: 1 day

  4. Participants With 1 mm ST Segment Depression During ETT-3

    ST Segment Depression measured by Electrocardiography while performing ETT-3.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionNov 2008
  4. Study completionMar 2009

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682565
Sponsor's protocol ID
CY 1221
Status last verified
Feb 2010
First submitted
20 May 2008
Last updated
21 Aug 2018

Publications

  • Greenberg BH, Chou W, Saikali KG, Escandon R, Lee JH, Chen MM, Treshkur T, Megreladze I, Wasserman SM, Eisenberg P, Malik FI, Wolff AA, Shaburishvili T. Safety and tolerability of omecamtiv mecarbil during exercise in patients with ischemic cardiomyopathy and angina. JACC Heart Fail. 2015 Jan;3(1):22-29. doi: 10.1016/j.jchf.2014.07.009. Epub 2014 Nov 11.

    PubMed 25453536

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CK-1827452 24mg and 6 mg iv infusion, CK-1827452 12.5mg capsule and CK-1827452 48 mg and 11 mg iv infusion in people with Heart Failure and Myocardial Ischemia, run by Cytokinetics at 14 sites in 2 countries.

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 12 inclusion and 14 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 25 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00682565, which also lists 1 linked publication.

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 21 Aug 2018.

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