check_circleStudy Completed
Hypertension
Bayer Identifier:
17677
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Blood Pressure Control of Nifedipine GITS 60mg Treatment in Chinese Hypertensive Subjects Uncontrolled on Starting-dose Mono-therapyo-therapy.
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
278Trial Dates
March 2015 - August 2016Phase
Phase 4Could I Receive a placebo
NoProducts
Adalat GITS (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Beijing, 100037, China | |
Completed | Shandong, China | |
Terminated | Tangshan, 063000, China | |
Completed | Beijing, 100028, China | |
Completed | Shandong, China | |
Completed | Tianjin, 300052, China | |
Completed | Xi'an, 710061, China | |
Completed | Hangzhou, 310006, China | |
Completed | Wudan, 430022, China | |
Completed | Shanghai, 200025, China | |
Completed | Changsha, 410008, China | |
Completed | fuzhou, 350001, China | |
Terminated | Beijing, China | |
Completed | Tangshang, China | |
Completed | Nanjing, 210008, China | |
Terminated | Tangshang, China | |
Terminated | Nanjing, 210008, China |
Primary Outcome
- Percentage of subjects with a Mean Sitting Systolic Blood Pressure (<130mmHg for subjects with diabetes and <140mmHg for others) of Nifedipine GITs 60mgdate_rangeTime Frame:At week 8enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Changes in the Mean Sitting SBP(MSSBP) and Mean Sitting DBP(MSDBP) from baseline at Week 8date_rangeTime Frame:baseline and week 8enhanced_encryptionNoSafety Issue:
- 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 60mgdate_rangeTime Frame:At week 2 and week 4enhanced_encryptionNoSafety Issue:
- The percentage of subjects with a MSDBP lower than 90 (80 for diabetis)date_rangeTime Frame:At week 2 and week 4enhanced_encryptionNoSafety Issue:
- The percentage of subjects achieving both a ≥10mmHgdate_rangeTime Frame:At week 8enhanced_encryptionNoSafety Issue:
- 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 diabetesdate_rangeTime Frame:up to week 8enhanced_encryptionNoSafety Issue:
- 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 8date_rangeTime Frame:baseline and week 8enhanced_encryptionNoSafety Issue:
- incidence of all treatment-emergent adverse eventsdate_rangeTime Frame:At week 8enhanced_encryptionYesSafety Issue:
- incidence of drug-related treatment-emergent adverse eventsdate_rangeTime Frame:at week 8enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1