NCT02047019

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil

A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects With Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone. Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone. Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure \>/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
DRUG	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
DRUG	Candesartan Cilexetil	Candesartan Cilexetil, 16 mg, capsule, orally, once daily
DRUG	Candesartan matching placebo	Candesartan matching placebo, capsule, orally, once daily
DRUG	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
DRUG	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)	Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-12-08
• Completion: 2019-12-08
• First posted: 2014-01-28
• Last updated: 2017-05-22

Locations

8 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study