Obese Hypertension Study (0954-315)

NCT00289887 | Completed Phase 3 Results

• 3 other identifiers: 0954-315MK0954-3152006_002
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

• Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8

  Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

• Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8

  Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

• Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

  Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

• Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12

  Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

• Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16

  Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

• Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16

  Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

  At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Study Arms (2)

1

EXPERIMENTAL

Losartan

Drug: Comparator: losartan +/- HCTZ

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

Comparator: losartan +/- HCTZ DRUG

Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.

1

Comparator: Placebo DRUG

Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.

2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese male and female patients, ages 21-75 years, with high blood pressure

You may not qualify if:

• Patients cannot have any other severe cardiac conditions

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6.

  PMID: 18328120 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2006
• First Posted: February 10, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 9, 2022
• Results First Posted: May 27, 2010

Record last verified: 2022-02