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A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009 AM1)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: MK-7145 (Drug); MK-7145 (Drug); Hydrochlorothiazide (HCTZ) (Drug); Placebo to MK-7145 (Drug); Placebo to HCTZ (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension.

Clinical Details

Official title: A Phase Ib, Randomized, Double-Blind, 4-Treatment, 2-Period Incomplete Block Study to Evaluate the Multiple Dose Effects of MK-7145 and Hydrochlorothiazide Compared to Placebo on Blood Pressure in Male Patients With Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Time-weighted average over 24 hours post dose (TWA [0-24]) in systolic blood pressure (SBP) with MK-7145 6 mg versus placebo

TWA[0-24] in systolic blood pressure (SBP) with MK-7145 6 mg versus hydrochlorothiazide (HCTZ)

Urinary sodium excretion (UNaV) for MK-7145 6 mg versus placebo

Secondary outcome:

TWA[0-24] in diastolic blood pressure (DBP) with MK-7145 6 mg versus HCTZ

TWA[0-24] in SBP with MK-7145 6 mg versus MK-7145 3 mg

TWA [0-24] in DBP with MK-7145 6 mg versus MK-7145 3 mg

Difference in urinary sodium excretion for MK-7145 6 mg versus placebo

Difference in urinary potassium excretion for MK-7145 versus placebo

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

Inclusion criteria:

- Diagnosis of essential hypertension

- Body mass index (BMI) ≤35 kg/m^2

- Participant in general good health

- No history of clinically significant arrhythmias or clinically significant

abnormality on electrocardiogram (ECG)

- No history of clinically significant cardiac disease

- Treatment-naïve or taking up to 2 antihypertensive therapeutic agents

- Non-smoker and/or has not used nicotine or nicotine-containing products for at least

6 months Exclusion criteria:

- Participant has low plasma potassium

- History of stroke, chronic seizures, or major neurological disorder

- History of clinically significant endocrine, gastrointestinal, cardiovascular,

hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

- History of osteoporosis

- Active or history of nephrocalcinosis, nephrolithiasis or hypercalciuria

- Orthostatic change in vital sign measurements while going from a semi-recumbent to

standing position accompanied by symptoms

- Functional disability that can interfere with rising from a semi-recumbent position

to the standing position

- History of malignant neoplastic disease. Exceptions: (1) adequately treated

non-melanomatous skin carcinoma; (2) other malignancies which have been successfully treated >10 years prior to the prestudy (screening) visit, (3) unlikely to sustain a recurrence

- Participant is unable to refrain from the use of prescription and non-prescription

drugs such as high-dose aspirin (≥325 mg/day), strong/moderate Cytochrome P450 3A4 (CYP3A4) inhibitors (such as ritonavir, indinavir, nelfinavir, erythromycin, telithromycin, clarithromycin, chloramphenicol, fluconazole, ketoconazole, itraconazole, nefazodone, aprepitant, verapamil, or diltiazem) as well as strong/moderate CYP3A4 inducers (such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, etravirine, rifampicin, modafinil, St Johns Wort, cyproterone, or progestin) beginning approximately 2 weeks (or 5 half-lives), prior to administration of the initial dose of study drug until the post study visit

- Current use of non-steroidal anti-inflammatory drugs (NSAIDs) other than low dose

aspirin, aluminum- or magnesium-containing antacids, sucralfate, metal cations such as iron, multivitamins containing iron or zinc that cannot be discontinued at least 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the post study visit

- Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of

alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day

- Participant consumes excessive amounts, defined as greater than 6 servings (1 serving

is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day

- Major surgery, donation or lost 1 unit of blood (approximately 500 mL), or

participation in another investigational study within 4 weeks prior to the prestudy (screening)

- History of significant multiple and/or severe allergies (including latex allergy), or

has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

- Regular use of any illicit drugs or history of drug abuse within approximately 6

months

- Dehydration or volume-depletion

Locations and Contacts

Additional Information

Starting date: June 2011
Last updated: April 20, 2015

Page last updated: August 23, 2015

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