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Completed

NCT Number: NCT01355367

High Dose BAYA1040 CR: a Long Term Extension Study

This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.

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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

Hirosaki, Aomori, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

Exclusion criteria

  • Patients with expected difficulties for the continuous 1 year follow up

Treatment and study plan

Nifedipine (Adalat, BAYA1040)

Drug

BAYA1040 CR 40mg BID

Primary outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: Week 52

Secondary outcomes

  1. Changes from baseline in diastolic blood pressure (DBP) while sitting

    Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

  2. Changes from baseline in systolic blood pressure (SBP) while sitting

    Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

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

    Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

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

    Time frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 18, 2011
Registry last updated
Jan 29, 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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