HealthyPhase 1NCT02129192

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use

A Phase 1 study testing Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet and T80/A5/H12.5 mg FDC tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ). Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet and T80/A5/H12.5 mg FDC tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteJapan
Study dates: May 2014to Sep 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Who cannot join

Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance

Trial locations and contacts

1 site in 1 country.

Japan1 site

Boehringer Ingelheim Investigational Site
Tokyo, Hachioji

Other trials in Japan

About this study

Official title: Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study), With Influence of Food on the Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet

To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).

Conditions: Healthy
Being tested: Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, T80/A5/H12.5 mg FDC tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine 5mg capsuleDrug
Amlodipine 5mg capsule
T80/H12.5 mg FDC tabletDrug
Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet
T80/A5/H12.5 mg FDC tabletDrug
Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet

Study groups in NCT02129192
Study group	Role	What they receive
T80/A5/H12.5 mg FDC	Experimental	Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet Receives: Drug: T80/A5/H12.5 mg FDC tablet
T80/H12.5 FDC + A5 mono	Active comparator	Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule Receives: Drug: Amlodipine 5mg capsule; Drug: T80/H12.5 mg FDC tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Measured Concentration (Cmax) of the Analytes in Plasma
Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet
Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration
Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet
Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

Secondary outcomes (2)

Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity
Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet
Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet
Measured: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Sep 2014

First posted2 May 2014 (estimated)
Study startMay 2014
Primary completionAug 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02129192
Sponsor's protocol ID: 1348.4
Status last verified: Mar 2017
First submitted: 30 Apr 2014
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study), With Influence of Food on the Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet
ClinicalTrials.gov ID: NCT02129192
Acronym / sponsor ID: 1348.4
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Aug 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 2 May 2014 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
T80/A5/H12.5 mg FDC	Experimental	Drug: T80/A5/H12.5 mg FDC tabletTelmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
T80/H12.5 FDC + A5 mono	Active comparator	Drug: Amlodipine 5mg capsule, Drug: T80/H12.5 mg FDC tabletTelmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2
Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Key exclusion criteria (1 listed)

Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine 5mg capsuleAmlodipine 5mg capsule	Drug	T80/H12.5 FDC + A5 mono
T80/H12.5 mg FDC tabletTelmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet	Drug	T80/H12.5 FDC + A5 mono
T80/A5/H12.5 mg FDC tabletTelmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet	Drug	T80/A5/H12.5 mg FDC

Primary outcome

Maximum Measured Concentration (Cmax) of the Analytes in Plasma
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma
Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet
Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration
Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet

2 secondary outcomes

Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only
Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet
Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence TRRTT	36	36
Sequence RTTR	36	35

Primary outcome: Maximum Measured Concentration (Cmax) of the Analytes in Plasma

Time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	T80/A5/H12.5 mg FDC n = 71	T80/H12.5 FDC + A5 Capsule n = 71
Telmisartan	697 (75.5)	726 (74.9)
Amlodipine	3.62 (20.2)	3.57 (19.9)
HCTZ	98.5 (25.1)	96.6 (25.8)

T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 95.77 (90% CI 88.89 to 103.17), Mixed Models Analysis
T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 101.40 (90% CI 99.70 to 103.13), Mixed Models Analysis
T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 101.77 (90% CI 98.46 to 105.19), Mixed Models Analysis

Population analysed: Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS.

Primary outcome: Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet

Measure	T80/A5/H12.5 mg FDC Fed n = 36	T80/A5/H12.5 FDC Fasted n = 36
Telmisartan	182 (75.9)	605 (84.4)
Amlodipine	3.54 (20.6)	3.60 (22.4)
HCTZ	75.4 (16.5)	94.6 (20.1)

T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 30.15 (90% CI 24.99 to 36.38), p = 1.0000, ANOVA
T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 98.23 (90% CI 94.63 to 101.97), p <0.0001, ANOVA
T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 79.69 (90% CI 74.97 to 84.71), p = 0.5422, ANOVA

Population analysed: Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation.

Primary outcome: Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration

Measure	T80/A5/H12.5 mg FDC n = 71	T80/H12.5 FDC + A5 Capsule n = 71
Telmisartan	2580 (76.8)	2600 (76.1)
Amlodipine	159 (23.4)	157 (24.0)
HCTZ	600 (21.0)	598 (19.1)

T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 99.21 (90% CI 96.14 to 102.38), Mixed Models Analysis
T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 101.43 (90% CI 99.84 to 103.04), Mixed Models Analysis
T80/A5/H12.5 mg FDC vs T80/H12.5 FDC + A5 Capsule: Adjusted geometric mean ratio (%): 100.33 (90% CI 98.29 to 102.40), Mixed Models Analysis

Population analysed: PKS

Primary outcome: Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet

Measure	T80/A5/H12.5 mg FDC Fed n = 36	T80/A5/H12.5 FDC Fasted n = 36
Telmisartan	1500 (98.3)	2350 (93.6)
Amlodipine	156 (23.9)	157 (26.1)
HCTZ	515 (18.9)	575 (19.2)

T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 63.66 (90% CI 58.98 to 68.71), p = 1.0000, ANOVA
T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 99.74 (90% CI 97.08 to 102.48), p <0.0001, ANOVA
T80/A5/H12.5 mg FDC Fed vs T80/A5/H12.5 FDC Fasted: Adjusted geometric mean ratio (%): 89.66 (90% CI 85.80 to 93.70), p = 0.0001, ANOVA

Population analysed: FEAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until end of washout period (14 days) or 144 hours after last drug administration (6 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T80/A5/H12.5 mg FDC	0 of 71 (0%)	11 of 71 (15.5%)	Not reported
T80/H12.5 FDC + A5 Capsule	0 of 72 (0%)	6 of 72 (8.3%)	Not reported
Total.	0 of 72 (0%)	16 of 72 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet and T80/A5/H12.5 mg FDC tablet in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Measured Concentration (Cmax) of the Analytes in Plasma (time frame: 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02129192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.