NCT01303783

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,381 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Essential

Interventions

Type	Name	Description
DRUG	Candesartan cilexetil (Atacand), 4 mg	4 mg of candesartan as capsule
DRUG	Candesartan cilexetil (Atacand), 8 mg	8 mg candesartan as capsule
DRUG	Nifedipine GITS (Adalat, BAYA1040), 20 mg	20 mg nifedipine as tablet
DRUG	Nifedipine GITS (Adalat, BAYA1040), 30 mg	30 mg nifedipine as tablet
DRUG	Nifedipine GITS (Adalat, BAYA1040), 60 mg	60 mg nifedipine as tablet
DRUG	Placebo	3 different placebo tablets corresponding nifedipine doses and 1 placebo capsule corresponding to candesartan doses
DRUG	Candesartan cilexetil (Atacand), 16 mg	16 mg of candesartan as capsule
DRUG	Candesartan cilexetil (Atacand), 32 mg	32 mg of candesartan as capsule

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-02-25
• Last updated: 2017-04-18

Locations

157 sites across 13 countries: United States, Argentina, Belgium, Brazil, Canada, Italy, Lithuania, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom