Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension

NCT02641821 | Unknown Phase 4

• 1 other identifier: Nifedipine-HT-1.0
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Control rate of hypertension evaluated by office blood pressure at 8 weeks

  8 weeks

• Control rate of hypertension evaluated by office blood pressure at 4 weeks

  4 weeks

• Control rate of hypertension evaluated by office blood pressure at 2 weeks

  2 weeks

Secondary Outcomes (3)

• Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks

  8 weeks

• Change of office blood pressure from baseline to 8 weeks

  8 weeks

• Change of 24-hour ABPM from baseline to 8 weeks

  8 weeks

Study Arms (1)

Nifedipine GITS

EXPERIMENTAL

Drug: Nifedipine GITS

Interventions

Nifedipine GITS DRUG

Nifedipine GITS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a seated systolic BP (SBP) ≥140 mmHg and \<180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and \<110 mmHg;
• an age ≥18 and ≤75 years;
• those who had not taken any BP-lowering medications in 1 month before the study.

You may not qualify if:

• a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
• secondary hypertension;
• diagnosed heart failure or stroke;
• Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine \>177 µmmol/L (2mg/dL), or liver cirrhosis;
• subjects with carotid stenosis or systolic murmur
• subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;
• subjects who were within lactation period, pregnant, or planning to become pregnant during the study;
• hypersensitive to Nifedipine GITS or with SAE;
• subjects who are participating in other clinical trials;
• considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).

Sponsors & Collaborators

• Peking University First Hospital: lead
• Bayer: collaborator

Study Sites (1)

Division of Cardiology, Peking University First Hospital

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yong Huo, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yu, MD

CONTACT

8610-83575262; jiyou_2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Cardiology

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

CN (1)