NCT01614366

DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

A Phase II Study to Explore the Effect of Different Dose of DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: TSH Biopharm Corporation Limited · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the different dose of DMTA07 (DM) combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy.

Detailed description

To compare the different dose of DM combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of DM in the combination therapy. The purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of DM combines with amlodipine treatment, further to explore the optimized combination dose of DM.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	AM 5 + DM 0	Amlodipine 5 mg + DMTA07 0mg, once daily
DRUG	AM 5 + DM 2.5	Amlodipine 5 mg + DMTA07 2.5mg, once daily
DRUG	AM 5 + DM 7.5	Amlodipine 5 mg + DMTA07 7.5mg, once daily
DRUG	AM 5 + DM 30	Amlodipine 5 mg + DMTA07 30mg, once daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-06-07
• Last updated: 2015-11-13

Locations

8 sites across 1 country: Taiwan