A study to test the effectiveness of a tablet containing both Nifedipine and Candesartan Cilexetil in adults with high blood pressure whose blood pressure is not well controlled with tablets containing 16 mg 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004493-26-DE

Enrollment

504

Registered

2013-05-10

Start date

2013-07-31

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension MedDRA version: 19.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Nifedipine GITS/Candesartan cilexetil 30/16 Product Code: BAY98-7106 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: NIFEDIPI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects 18 years or older are eligible. 2. At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP of = 160 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range 252

Exclusion criteria

Exclusion criteria: 1. MSSBP = 200 mmHg and/or MSDBP = 120 mmHg 2. MSDBP 3 x upper limit of normal (ULN) at Screening Visit - Renal insufficiency, defined as estimated glomerular filtration rate (estimated GFR) of < 30 mL/min (see Section 7.6.3), or on hemodialysis 19. For subjects with renal impairment, reduction of estimated GFR = 30% at Visit 2 compared with Screening visit as confirmed by a repeat laboratory test performed within 1 week 20. Investigational study participation with receipt of investigational study medication within the last month

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate the efficacy of two FDCs of nifedipine GITS and candesartan cilexetil compared to candesartan cilexetil monotherapy in subjects not adequately controlled on candesartan cilexetil alone, based on reduction of mean seated systolic blood pressure (MSSBP).; Secondary Objective: - To demonstrate the efficacy of the FDCs of Nifedipine GITS/ candesartan cilexetil based on reduction of mean seated diastolic blood pressure (MSDBP), response rate and control rate - To demonstrate the efficacy of the FDCs of Nifedipine GITS/ candesartan cilexetil based on reduction of mean diastolic blood pressure (DBP) and systolic blood pressure (SBP) on ABPM over a 24-h period, during both the daytime and night-time. - To explore the safety and tolerability of the FDC treatments ;Primary end point(s): The primary efficacy variable will be change from baseline in MSSBP at Week 8.;Timepoint(s) of evaluation of this end point: Week 8	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate the efficacy of two FDCs of nifedipine GITS and candesartan cilexetil compared to candesartan cilexetil monotherapy in subjects not adequately controlled on candesartan cilexetil alone, based on reduction of mean seated systolic blood pressure (MSSBP).; Secondary Objective: - To demonstrate the efficacy of the FDCs of Nifedipine GITS/ candesartan cilexetil based on reduction of mean seated diastolic blood pressure (MSDBP), response rate and control rate - To demonstrate the efficacy of the FDCs of Nifedipine GITS/ candesartan cilexetil based on reduction of mean diastolic blood pressure (DBP) and systolic blood pressure (SBP) on ABPM over a 24-h period, during both the daytime and night-time. - To explore the safety and tolerability of the FDC treatments ;Primary end point(s): The primary efficacy variable will be change from baseline in MSSBP at Week 8.;Timepoint(s) of evaluation of this end point: Week 8

—

Secondary

Measure	Time frame
Secondary end point(s): As a secondary endpoint, this study will evaluate DBP reductions, as well as predefined response, control criteria and the mean change in SBP and DBP on ABPM over 24-hour period, during both daytime and night time at Week 8;Timepoint(s) of evaluation of this end point: Week 8	—

Countries

Argentina, Belgium, Canada, Czech Republic, France, Germany, Lithuania, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026