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Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine(Adalat_BAY1040) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Summary

To evaluate antihypertensive efficacy and tolerability of Nifedipine GITS 60mg treated for 8 weeks in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive monotherapy.

Clinical Details

Official title: Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapy: A Prospective, Open-label, Multicenter, Single-arm, 8-week Study.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mg

Secondary outcome:

Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8

Percentage of subjects with a Mean Sitting Systolic Blood Pressure Lower than 140mmHg and MSDBP less than 90 mmHg (130 and 80 for diabetis patients) of Nifedipine GITs 60mg

The percentage of subjects with a MSDBP lower than 90 (80 for diabetis).

The percentage of subjects achieving both a ≥10mmHg

Time to reach the MSSBP target (based on the BP measurements during office visits)

Changes in the 24-h, daytime (from 06:00 to 22:00), and nighttime (from 22:00 to 06:00) average SBP and DBP assessed by ABPM from baseline at Week 8

incidence of all treatment-emergent adverse events

incidence of drug-related treatment-emergent adverse events

Detailed description: Study design: it's a A prospective, open-label, multicenter, single-arm study. After a one- to two-week screening period, subjects receive Nifedipine GITS 60mg for 8 weeks. The primary objective is to evaluate the antihypertensive efficacy of 8-week Nifedipine GITS 60mg treatment in Chinese hypertensive subjects who failed to achieve BP control with the starting-dose antihypertensive mono-therapy. The secondary objective is to evaluate the tolerability of Nifedipine GITS 60mg.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects are eligible to be included in the study only if they meet all of the

following criteria:

- Aged 18 years or older, but less than 65 years;

- Either male or female

- BP is uncontrolled after at least 4 weeks of prior antihypertensive mono-therapy (the

dosage of mono-therapy should be the starting dose of an angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), b-blocker (BB), calcium channel blocker (CCB), or diuretic) both in the beginning and at the end of the screening period (uncontrolled BP is defined as MSSBP ≥140 and <160mmHg and/or MSDBP ≥ 90 and <100mmHg, and in the presence of diabetes mellitus: MSSBP ≥130 and <160mmHg and/or MSDBP ≥80 and <100mmHg); Exclusion Criteria:

- Subjects meeting any of the following criteria are to be excluded from the study:

- Known hypersensitivity to nifedipine or to any of the following excipients,

hypromellose, polyethylene oxide, magnesium stearate, sodium chloride, iron oxide red (E172/C. I.77491), cellulose acetate, polyethylene glycol 3350, hydroxypropyl cellulose, propylene glycol, titanium dioxide (E171/C. I.77891)

- Evidence of secondary hypertension such as coarctation of the aorta,

pheochromocytoma, hyperaldosteronism, etc. Severe gastro-intestinal tract narrowing; gastric banding; kock pouch (ileostomy after proctocolectomy)

- Evidence of cardiovascular shock

- Pregnant, possibly pregnant, planning to become pregnant or lactating women Received

combination (two or more than two drugs combination) therapy or higher dosage (a higher dosage is defined as a higher dosage than the standard recommended starting dosage presented in the label of each drug) mono-therapy in the beginning or at the ending of the screening period.

- History of cerebrovascular ischemic event (stroke or transient ischemic attack

[TIA]) within 6 months

- History of intracerebral hemorrhage or subarachnoid hemorrhage

- History of hypertensive retinopathy

- Any history of heart failure, New York Heart Association (NYHA) classification III or

IV Severe coronary heart disease as manifested by a history of myocardial infarction or unstable angina in the past 12 months or a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

- Clinically significant cardiac valvular disease

- History of arrhythmia

- Type 1 diabetes mellitus (DM)

- Hyperkalemia history: a serum potassium level above the upper limit of normal in the

laboratory range;

- Liver disease or aspartate transaminase (AST) or alanine transaminase (ALT) levels >3

x upper limit of normal (ULN)

- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) of <30

mL/min, or on hemodialysis

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Beijing 100028, China; Not yet recruiting

Beijing 100037, China; Not yet recruiting

Beijing 100037, China; Recruiting

Shanghai 200025, China; Not yet recruiting

Tianjin 300052, China; Recruiting

Fuzhou, Fujian, China; Recruiting

Tangshan, Hebei 063000, China; Recruiting

Wudan, Hubei 430022, China; Recruiting

Wuhan, Hubei 430022, China; Recruiting

Changsha, Hunan 410008, China; Not yet recruiting

Changsha, Hunan 410008, China; Terminated

Xi'an, Shanxi 710061, China; Recruiting

Hangzhou, Zhejiang 310006, China; Not yet recruiting

Additional Information

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Starting date: March 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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