Phase 3
Completed N=508
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Source: ClinicalTrials.gov NCT01788358 ↗Enrolled (actual)
508
Serious AEs
2.9%
Results posted
Aug 2015
Primary outcomePrimary: Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 — 390; 230 Subjects
Summary
This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.
Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).
Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 |
390; 230 | — |
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 |
124; 54; 7; 31; 15; 3 | — |
| PRIMARY Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) |
404; 238 | — |
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS) |
131; 56; 7; 31; 17; 3 | — |
| SECONDARY Number of Subjects With Clinically Relevant Changes in Laboratory Parameters |
— | — |
| SECONDARY Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52 |
170.7; -30.4; -30.1 | — |
| SECONDARY Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52 |
95.6; -12.7; -12.8 | — |
| SECONDARY Blood Pressure Control Rate at Weeks 28 and 52 |
51.4; 51.6 | — |
| SECONDARY Blood Pressure Response Rate at Weeks 28 and 52 |
86.6; 86.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of >/= 160 mmHg and /= 160 mmHg and /= 200 mmHg and/or mean seated diastolic blood pressure >/= 120 mm/Hg
- Mean seated diastolic blood pressure < 60 mm/Hg
- Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
- Any history of hypertensive emergency
- Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
- Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months
- History of intracerebral hemorrhage or subarachnoid hemorrhage
- History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
- Any history of heart failure, New York Heart Association (NYHA) classification III or IV
- Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
- Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
- Hyperkalemia: potassium above the upper limit of normal in the laboratory range
Data sourced from ClinicalTrials.gov (NCT01788358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.