drugset / Trial / NCT01788358

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

NCT01788358

Phase 3 Completed 508 enrolled Bayer
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-02-14
Primary completion
2014-05-01
Completion
2014-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Candesartan cilexetil Unknown 8 mg Oral
Subject Candesartan cilexetil Unknown 16 mg Oral
Subject Candesartan cilexetil Unknown 32 mg Oral
Subject Nifedipine Other / unclassified 30 mg Oral
Subject Nifedipine Other / unclassified 60 mg Oral