Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

Who is this study for? Patients with Type 2 Diabetes Mellitus, High Blood Pressure
What treatments are being studied? Allisartan Isoproxil+Amlodipine
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 79
Healthy Volunteers: f
View:

• irrespective of sex;

• aged between 45 and 79 years;

• with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;

• diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;

• informed consent provided and long-term follow-up possible

Locations
Other Locations
China
Guangdong General Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Jiyan Chen, MD
chen-jiyan@163.com
86-13802911148
Time Frame
Start Date: 2018-02-01
Estimated Completion Date: 2025-09
Participants
Target number of participants: 11414
Treatments
Active_comparator: intensive treatment group
Real antihypertensive agents will be provided for this arm, to decrease systolic BP to lower than 120 mm Hg. In this group, the following study medications will be used: tablets with Allisartan Isoproxil 240 mg (first-line medication); tablets with Amlodipine 5 mg (second-line medication). Treatment will be started with Allisartan 240 mg. If necessary to reach the BP goal, Amlodipine (first 5 mg or then 10 mg daily) will be given in addition. If intolerable side effects occur, first-line medication may be replaced by second-line medication.
Placebo_comparator: standard treatment group
In this arm participants are followed up and no medications be used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.
Related Therapeutic Areas
Sponsors
Leads: XueQing Yu

This content was sourced from clinicaltrials.gov