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

NCT02413515 | Completed Phase 4

• 1 other identifier: 17677
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  At week 8

Secondary Outcomes (8)

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

  baseline and 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

  At week 2 and week 4

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

  At week 2 and week 4

• The percentage of subjects achieving both a ≥10mmHg

  At week 8

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

  up to week 8

Study Arms (1)

Arm 1

EXPERIMENTAL

Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks

Drug: Nifedipine (Adalat GITS, BAY1040)

Interventions

Nifedipine (Adalat GITS, BAY1040) DRUG

Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (14)

Unknown Facility

Fuzhou, Fujian, 350001, China

Location

Unknown Facility

Tangshan, Hebei, 063000, China

Location

Unknown Facility

Wudan, Hubei, 430022, China

Location

Unknown Facility

Changsha, Hunan, 410008, China

Location

Unknown Facility

Nanjing, Jiangsu, 210008, China

Location

Unknown Facility

Xi’an, Shanxi, 710061, China

Location

Unknown Facility

Hangzhou, Zhejiang, 310006, China

Location

Unknown Facility

Beijing, 100028, China

Location

Unknown Facility

Beijing, 100037, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Shandong, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Tangshang, China

Location

Unknown Facility

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 10, 2015
• Study Start: March 26, 2015
• Primary Completion: August 8, 2016
• Study Completion: August 8, 2016
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

CN (14)