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NCT Number: NCT01294215

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ebina, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 years or older
  • Japanese male or female
  • Outpatient with essential hypertension
  • Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion criteria

  • Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
  • Patients with secondary hypertension or hypertensive emergency

Treatment and study plan

Nifedipine (Adalat, BAYA1040)

Drug

Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)

Primary outcomes

  1. Efficacy changes measured by sitting diastolic blood pressure (DBP)

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Efficacy changes measured by sitting systolic blood pressure (SBP)

    Time frame: Up to 52 weeks

  2. Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines

    Time frame: Up to 52 weeks

  3. Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP

    Time frame: Up to 52 weeks

  4. Safety variables

    Time frame: Up to 30 days after the last dose of study drug

    Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 11, 2011
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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