Conditions: Hypertension
Keywords: Drug combination Nifedipine GITS Candesartan Cilexetil Hypertension Combination therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 508
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).

Interventions: intervention 1: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 2: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 3: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) intervention 4: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention descriptions: intervention 1: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily intervention 2: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily intervention 3: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily intervention 4: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily

Protocol document: