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An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

ConditionHypertension (HTN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent must be obtained prior to participation in the study.

Successful completion of treatment period on QCZ484 study medication in parent study.

No significant safety issue that may place participant at safety risk as determined by the Investigator.

Disqualifiers

Evidence of hepatic disease that would put participant at risk by taking QCZ484 for long term as determined by the Investigator.

Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade atrioventricular (AV) block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) developed during the parent study.

Permanent or persistent atrial fibrillation developed during the parent study.

Clinically significant valvular heart disease developed during the parent study.

Trial design

Design model

Single group

Treatments tested in this trial

  • QCZ484

    Drug

    QCZ484 subcutaneous injection, Q6M.

Treatment groups

323 Participants
are divided into 1 treatment group
Group A: QCZ484Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with AEs

Number of participants with Adverse events (AEs), including abnormal safety laboratory parameters and vital signs

Time frame
Up to 66 months

Secondary outcomes

1

Change in SBP and DBP assessed by ambulatory blood pressure monitoring

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline (parent study) and from Day 1 of the OLE and at Months 12 and so on (every 12 months) assessed by assessed by ambulatory blood pressure monitoring (ABPM) - applicable only for the subgroup of participants who had ABPM in the parent study

Time frame
Baseline (parent study), Day 1 (OLE study) and up to month 60 (OLE study)
2

Change in SBP and DBP assessed by office blood pressure measurement

Change in SBP and DBP from Baseline (parent study) and from Day 1 of the OLE and at Months 6, 12 and so on (Q6M) assessed by assessed by office blood pressure measurement (OBPM)

Time frame
Baseline (parent study), Day 1 (OLE study) and up to month 66 (OLE study)

Other outcomes

Sponsors and contacts

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Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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