Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension — DISTINCT

Hypertension, Essential Clinical Trial

Official title:
A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients With Essential Hypertension

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01303783
Study type	Interventional
Source	Bayer
Contact
Status	Completed
Phase	Phase 2
Start date	April 2011
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06448962` - Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022	Phase 3
Completed	`NCT01227603` - Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions	Phase 1
Completed	`NCT03258489` - Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients	N/A
Terminated	`NCT02245230` - Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension	Phase 1
Completed	`NCT05631990` - A Study to Evaluate the Efficacy and Safety of AD-209	Phase 2
Completed	`NCT02466490` - Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension	Phase 3
Completed	`NCT01350609` - Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed	Phase 1
Not yet recruiting	`NCT04332562` - The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension	N/A