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

NCT01303783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1381

Last updated 2017-04-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Italy
  • Lithuania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303783 on ClinicalTrials.gov