Trial to Evaluate the Efficacy and Safety of HCP1302

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Erectile Dysfunction

Treatments: Drug: Placebo (for HCP1302); Drug: HGP0904; Drug: Placebo (for HGP0904); Drug: HCP1302

Study type: Interventional

Funder types: Industry

Identifiers

NCT02587988

HM-TARO-301

Details and patient eligibility

About

Trial to Evaluate the Efficacy and Safety of HCP1302

Full description

A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904

Enrollment: 232 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

At Visit1

1. ≥19 age
2. Hypertension Patients who need amlodipine 5mg
3. Abnormal Erectile function ≥ at least 3months based on screening date
4. Patients who are expected to frequent use of Tadalafil (at least two times for weeks)
5. Patients understood the consents and purpose of this trial and signed informed consent form

At Visit2

1. 90≤ sitSBP < 140 mmHg and 50 ≤ sitDBP < 90 mmHg
2. Sexual dysfunction rate ≥ 50% for 4 weeks run-in period
3. International Index of Erectile Function(IIEF)- Erectile Function(EF) domain score ≤ 25

Exclusion Criteria:

1. History of hypersensitivity to Amlodipine or Tadalafil
2. Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
3. Has a clinically significant renal failure (Scr > 2mg/dl)
4. Uncontrolled diabetes mellitus (HbA1C >12%)
5. At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
6. Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
7. No reaction to PDE-5 inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups

HCP1302+HGP0904Placebo

Experimental group

Description:

HCP1302+HGP0904Placebo for 12weeks

Treatment:

Drug: Placebo (for HGP0904)

Drug: HCP1302

HCP1302Placebo+HGP0904

Active Comparator group

Description:

HCP1302Placebo+HGP0904 for 12weeks

Treatment:

Drug: Placebo (for HCP1302)

Drug: HGP0904