NCT00775814

Brief Summary

The purpose of this study is to determine the efficacy of candesartan, once daily (QD), combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese patients with hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

October 16, 2008

Last Update Submit

August 6, 2012

Conditions

ObesityHypertension

Keywords

HypertensionDrug TherapyBlood PressureInsulin, Resistant

Outcome Measures

Primary Outcomes (1)

  • The change from Baseline in Blood pressure (mean reduction in Diastolic Blood Pressure measured at trough).

    End of Treatment

Secondary Outcomes (11)

  • The change from Baseline in Adiponectin.

    At Final Visit.

  • The change from Baseline in high sensitivity C-Reactive Protein.

    At Final Visit.

  • The change from Baseline in Fasting Plasma Glucose.

    At Final Visit.

  • The change from Baseline in Fasting Plasma Insulin.

    At Final Visit.

  • The change from Baseline in Insulin Resistance (assessed by Homeostasis Model Assessment Insulin Resistance).

    At Final Visit.

  • +6 more secondary outcomes

Study Arms (2)

Candesartan + Hydrochlorothiazide QD

EXPERIMENTAL
Drug: Candesartan and Hydrochlorothiazide

Hydrochlorothiazide QD

ACTIVE COMPARATOR
Drug: Hydrochlorothiazide (HCT)

Interventions

Candesartan and HydrochlorothiazideDRUG

Candesartan 8 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for 2 weeks; increased to Candesartan 16 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.

Also known as: BLOPRESS PLUS®
Candesartan + Hydrochlorothiazide QD
Hydrochlorothiazide (HCT)DRUG

Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.

Hydrochlorothiazide QD

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has an Abdominal obesity with a waist circumference greater than 102 cm (men) and greater than 88 cm (women).
  • Has a body mass index greater than 30 kg/m\^2.
  • Has hypertension not adequately controlled (seated diastolic blood pressure greater than 95 mmHg and less than or equal to 110 mmHg as median value of three readings) by monotherapy with either beta-blocker or calcium channel blocker.
  • Has a Homeostasis Model Assessment Insulin Resistance index greater than 3.99.
  • Has hyperlipidemia with fasting levels for total cholesterol greater than 250 mg/dL (6.45 mmol/L) or low-density lipoprotein cholesterol greater than 160 mg/dL (4.13 mmol/L) or triglycerides greater than 250 mg/dL (2.82 mmol/L).

You may not qualify if:

  • Existing Hydrochlorothiazide therapy at start of study.
  • Diabetes mellitus type 1 or 2 \[known or newly detected (Screening: fasting plasma glucose greater than 7.0 mmol/L)\].
  • Chronic renal impairment or S-creatinine greater than or equal to 1.8 mg/dL.
  • Presence of single kidney or state after kidney transplantation or known bilateral renal artery stenosis or interventional treatment for renal artery stenosis in the last year.
  • Hyperkalemia (potassium greater than 5.5 mmol/L).
  • Known electrolyte imbalance, e.g. hypocalcaemia or hypokalemia resistant to treatment.
  • Nephrotic syndrome.
  • Thyroid dysfunction.
  • Primary or secondary hyperaldosteronism.
  • Cushing syndrome.
  • Known or suspected familial hypercholesterolemia.
  • Severe hepatic impairment (cholestasis (bilirubin greater than 2.0 mg/dL) or alanine aminotransferase and/or aspartate aminotransferase greater than 3 times the upper limit of normal and/or γ-glutamyl transpeptidase greater than 5 times the upper limit of normal).
  • History of chronic heart failure.
  • History of overt coronary heart disease.
  • History of silent myocardial infarction.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Bad Dürrheim, Baden-Wurttemberg, Germany

Location

Unknown Facility

Balingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Deggingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Rottweil, Baden-Wurttemberg, Germany

Location

Unknown Facility

Spaichingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Ingolstadt, Bavaria, Germany

Location

Unknown Facility

München, Bavaria, Germany

Location

Unknown Facility

Passau, Bavaria, Germany

Location

Unknown Facility

Schauenburg, Hesse, Germany

Location

Unknown Facility

Bocholt, North Rhine-Westphalia, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Isselburg, North Rhine-Westphalia, Germany

Location

Unknown Facility

Roetgen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Troisdorf, North Rhine-Westphalia, Germany

Location

Unknown Facility

Wesseling, North Rhine-Westphalia, Germany

Location

Unknown Facility

Rödersheim-Gronau, Rhineland-Palatinate, Germany

Location

Unknown Facility

Dresden, Saxony, Germany

Location

Unknown Facility

Freital, Saxony, Germany

Location

Unknown Facility

Machem, Saxony, Germany

Location

Unknown Facility

Markkleeberg, Saxony, Germany

Location

Unknown Facility

Wermsdorf, Saxony, Germany

Location

Unknown Facility

Bad Segeberg, Schleswig-Holstein, Germany

Location

Unknown Facility

Berlin, State of Berlin, Germany

Location

MeSH Terms

Conditions

ObesityHypertensionInsulin Resistance

Interventions

candesartanHydrochlorothiazidecandesartan cilexetil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Medical Director

    Takeda Pharma Gmbh, Aachen (Germany)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 20, 2008

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

DE(24)