Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Hypertension
Interventions
DRUG

Bisoprolol/Amlodipine (Bisoprolol failed group)

Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).

DRUG

Bisoprolol/Amlodipine (Amlodipine failed group)

Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).

Trial Locations (1)

Unknown

Please contact the Merck KGaA Communication Center located in, Darmstadt

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01977794 - Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension | Biotech Hunter | Biotech Hunter