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

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Nifedipine (Adalat GITS, BAY1040)

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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Beijing, China, 100037
  • Beijing, China, 100028
  • Shandong, China
  • Shanghai, China, 200025
  • Tangshang, China
  • Tianjin, China, 300052
  • Fujian
    • Fuzhou, Fujian, China, 350001
  • Hebei
    • Tangshan, Hebei, China, 063000
  • Hubei
    • Wudan, Hubei, China, 430022
  • Hunan
    • Changsha, Hunan, China, 410008
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
  • Shanxi
    • Xi'an, Shanxi, China, 710061
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Single arm study,the eligible subjects will receive Nifedipine GITS 60mg for 8 weeks	Drug: Nifedipine (Adalat GITS, BAY1040); Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The MSSBP target means : 140 mmHg for others, 130 mmHg for diabetes	up to week 8
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		baseline and week 8
incidence of all treatment-emergent adverse events		At week 8
incidence of drug-related treatment-emergent adverse events		at week 8

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2015
• Primary Completion (Actual): August 8, 2016
• Study Completion (Actual): August 8, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: 17677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No