Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

Alvogen

Status and phase: Withdrawn; Phase 3

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: C1-R212; Drug: C2-R212; Drug: DP-R212

Study type: Interventional

Funder types: Industry

Identifiers

NCT02955368

DP-CTR212-III-03

Details and patient eligibility

About

The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both man and woman who is over 19 years old
• Hypertension patient with hypercholesterolemia

Exclusion criteria

• sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg
• A history of cardiovascular disease
• rhabdomyolysis, myopathy
• Hypertension or hypercholesterolemia due to secondary causes
• Uncontrolled diabetes
• Evidence of hepatic or renal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

DP-R212 group

Experimental group

Description:

DP-R212 + C1-R212 placebo + C2-R212 placebo

Treatment:

Drug: DP-R212

C1-R212 group

Active Comparator group

Description:

DP-R212 placebo + C1-R212 + C2-R212 placebo

Treatment:

Drug: C1-R212

C2-R212 group

Active Comparator group

Description:

DP-R212 placebo + C1-R212 placebo + C2-R212

Treatment:

Drug: C2-R212