CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 508 enrolled
Drug / intervention
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) +3 moredrug
Likely dose
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01788358
NCT01788358Phase 3Completed

Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension

Bayer·interventional·Posted Feb 11, 2013·Updated Oct 24, 2017

In Brief

A Phase 3 clinical trial evaluating Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) for Hypertension. Completed, enrolled 508 participants across 82 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Canada, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2013
Enrollment StartFeb 14, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.4 years ago

Interventions

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)drug

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)drug

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)drug

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)drug

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily